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A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Primary Purpose

Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL), Philadelphia Chromosome-Like ALL (Ph-like ALL)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ponatinib
Ponatinib AAF
Chemotherapy Agents
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL) focused on measuring Drug Therapy

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants must have a diagnosis of Ph+ ALL, Philadelphia chromosome-positive plus mixed phenotype acute leukemia (Ph+ MPAL), or Ph-like ALL (US only) with:

    a) Involvement of BM with ALL, including one of the following: i. M2 BM (5%-24% lymphoblasts): by morphology with confirmatory testing consisting of at least one of the following: flow cytometry lymphoblasts ≥5%, or BCR-ABL1 fluorescence in situ hybridization, or ≥10-2 leukemic clone identified by immunoglobulin heavy chain-T-cell receptor polymerase chain reaction, OR ii. M3 BM (≥25% lymphoblasts): by morphology, OR iii. Participants with combined BM (as defined above) and extramedullary disease.

    b) Evidence of Ph+ ALL, MPAL, or Ph-like ALL: i. Definite evidence of BCR-ABL1 fusion (Ph) for Ph+ All and MPAL, OR ii. Definite evidence of Ph-like ALL (US only) with targetable kinase-activating lesions involving any of the following kinase genes: ABL1, ABL2, CSF1R, and PDGFRB.

    and either (i) or (ii) as follows: (i) For non-US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a BCR-ABL-targeted tyrosine kinase inhibitor (TKI), or for US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a second-generation BCR-ABL1-targeted TKI (i.e, dasatinib, nilotinib, and bosutinib) (ii) Have a BCR-ABL1 T315I mutation irrespective of relapse, resistance/intolerance, or transplant status and irrespective of any prior TKI use.

    Notes:

    A participant will be defined as intolerant if they had a Grade ≥3 nonhematologic toxicity or a Grade 4 hematologic toxicity considered at least possibly related to the last TKI and lasting for >2 weeks, and led to discontinuation of therapy.

    Participants with Ph-like ALL (US only): Referring institution's laboratory results will be accepted for study enrollment.

  2. Performance Status: Karnofsky performance status ≥50% for participants >16 years of age or Lansky Play Scale ≥50% for participants ≤16 years of age.
  3. Have recovered to less than Grade 2 National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 5, or to baseline, from any nonhematologic toxicities (except alopecia) due to previous therapy.
  4. Participants must meet the following criteria related to prior therapies:

    • Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy.
    • Participants who relapsed while receiving cytotoxic therapy: At least 14 days must have passed since the completion of the last dose of chemotherapy before the first dose of ponatinib can be given except for the following: intrathecal (IT) chemotherapy and/or maintenance therapy such as vincristine, mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance-like therapy.
    • HSCT: Participants who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment.
    • Hematopoietic growth factors: Before the first dose of ponatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days must have passed since completion of therapy with pegfilgrastim.
    • Biologics and Targeted Therapies: Before the first dose of ponatinib, at least 7 days must have passed since the last dose of a biologic agent. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor's medical monitor/designee.
    • Monoclonal antibodies: After the last dose of monoclonal antibody, at least 3 half-lives of the administered antibody must have passed before the first dose of ponatinib.
    • Immunotherapy: Before the first dose of ponatinib, at least 30 days must have passed after the completion of any type of immunotherapy (eg, tumor vaccines, chimeric antigen receptor T-cell [CAR-T-cell]).
    • Immunosuppressive therapy: Before the first dose of ponatinib, at least 14 days must have passed after the completion of immunosuppressive therapy (including regimens following stem cell transplant).
    • Radiotherapy: No washout period is necessary for radiation given to any extramedullary site other than central nervous system (CNS); ≥90 days must have passed if participant received prior total body irradiation or craniospinal or cranial radiotherapy.
    • Anthracyclines: Participants must have had a lifetime exposure of <400 mg/m^2 of doxorubicin equivalents of anthracyclines.
  5. a) Adequate renal function defined as: Estimated glomerular filtration rate (eGFR) using the Schwartz formula, OR radioisotope glomerular filtration rate (GFR)≥70 mL/min/1.73 m^2, OR a normal serum creatinine based on age and sex.

    b)Adequate liver function defined as: Direct bilirubin ≤1.5 times the upper limit of normal (ULN) for age AND ALT ≤5 times the ULN for age.

  6. No clinical, radiological or laboratory evidence of pancreatitis, including:

    1. Serum lipase must be <2 times the ULN, and
    2. Serum amylase must be <2 times the ULN.
  7. Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by multigated acquisition scan (MUGA).

Exclusion Criteria:

  1. A history or current diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia.
  2. A history or current diagnosis of chronic myeloid leukemia (CML).
  3. Diagnosis of ALL, MPAL, or Ph-like ALL (US only) with targetable kinase-activating lesions after treatment with cytotoxic therapy for another cancer.
  4. Diagnosis of another concurrent primary malignancy.
  5. Clinically significant cardiovascular disease, including but not limited to:

    1. Any history of myocardial infarction (MI) or unstable angina.
    2. History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias.
    3. Uncontrolled hypertension, defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.
  6. Current systemic use of drug(s) that are known to have a risk of causing prolonged corrected QT interval (QTc) or torsades de pointes unless drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system) or the participants can safely discontinue the drug(s).
  7. Uncontrolled hypertriglyceridemia (triglycerides ≥450 mg/dL).
  8. Current systemic use of any medications or herbal supplements that are known to be strong inhibitors or strong inducers of CYP3A within 7 days before the first dose of study drug.
  9. Previous treatment with ponatinib.
  10. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while participant is on study treatment.
  11. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption of ponatinib.
  12. Participants with DNA fragility syndromes, such as Fanconi anemia and Bloom syndrome.
  13. Participants with Down syndrome.
  14. Participants with uncontrolled systemic infection, or known laboratory and/or clinical evidence of active infection with HIV, hepatitis B, or hepatitis C.
  15. Participants with pre-existing significant CNS pathology including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible.
  16. Participants with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. (Participants with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits and causative factor(s) have resolved).
  17. Uncontrolled seizure disorder. (Participants with seizure disorders that do not require antiepileptic drugs or are well controlled with stable doses of antiepileptic drugs are eligible).
  18. History of severe coagulopathy or cardiovascular or peripheral vascular events.
  19. Treatment with live attenuated vaccinations within 30 days prior to initiation of study treatment regimen.

Sites / Locations

  • Phoenix Childrens HospitalRecruiting
  • Arkansas Children's HospitalRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Rady Childrens Hospital San Diego - PINRecruiting
  • UCSF Medical Comprehensive CancerRecruiting
  • Alfred I Dupont Hospital For ChildrenRecruiting
  • Ann and Robert H Lurie Childrens Hospital of ChicagoRecruiting
  • Riley Hospital For ChildrenRecruiting
  • Dana Farber Cancer Institute
  • Children's Mercy Hospital and ClinicaRecruiting
  • Cincinnati Children's Hospital Medical Center - PINRecruiting
  • Nationwide Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • St Jude Children's Research HospitalRecruiting
  • Childrens Medical Center Research Institute at UT SouthwesternRecruiting
  • Hospital Universitario AustralRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Queensland Childrens HospitalRecruiting
  • Royal Children's Hospital Melbourne - PINRecruiting
  • Perth Childrens HospitalRecruiting
  • Rua Ramiro Barcelos, 2350Recruiting
  • Irmandade Da Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDSRecruiting
  • Clinica SUPRA
  • Fundacao Pio XII Hospital de Cancer de BarretosRecruiting
  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USPRecruiting
  • Graacc Grupo de Apoio Ao Adolescente E A Crianca Com CancerRecruiting
  • Hospital Santa MarcelinaRecruiting
  • West China Second University Hospital, Sichuan UnivesityRecruiting
  • Children's Hospital of Chongqing Medical UniversityRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Qilu Hospital of Shandong University
  • The Affiliated Hospital of Qingdao University
  • Children's Hospital of ShanghaiRecruiting
  • Shanghai Childrens Medical CenterRecruiting
  • Children's Hospital of Soochow UniversityRecruiting
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • Hopital SudRecruiting
  • Assistance Publique Hopitaux de MarseilleRecruiting
  • Hopital Robert DebreRecruiting
  • Hopital Des EnfantsRecruiting
  • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PINRecruiting
  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PINRecruiting
  • Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia VergaRecruiting
  • Ospedale Infantile Regina Margherita - INCIPIT - PINRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital Yonsei University Health SystemRecruiting
  • Asan Medical Center - PPDSRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Hospital Universitario Dr. Jose Eleuterio GonzalezRecruiting
  • Instituto Nacional de PediatriaRecruiting
  • Nuevo Hospital Civil de Guadalajara Dr. Juan I. MenchacaRecruiting
  • Princess Maxima Center for Pediatric Oncology - PINRecruiting
  • Uniwersytecki Szpital DzieciecyRecruiting
  • SPZOZ Centralny Szpital Kliniczny UM w LodziRecruiting
  • SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu MedycznegoRecruiting
  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Recruiting
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDSRecruiting
  • Hospital Universitario Vall d'Hebron - PPDSRecruiting
  • Hospital Infantil Universitario Nino Jesus - PINRecruiting
  • Hospital Universitario Virgen del Rocio - PPDSRecruiting
  • Royal Marsden Hospital - SurreyRecruiting
  • Birmingham Childrens Hospital
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • Royal Hospital for Children (Glasgow) - PPDS - PINRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ponatinib

Arm Description

Ponatinib tablet or age appropriate formulation (AAF) [i.e., capsules with ponatinib minitablets], based on age and weight, in combination with chemotherapy backbone, orally, once daily in both reinduction block and consolidation block (35 days each including 29 days of treatment followed by rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only) in Phase 1 to determine RP2D. In Phase 2 participants will receive ponatinib at RP2D in combination with chemotherapy backbone.

Outcomes

Primary Outcome Measures

Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy
The RP2D is the maximum tolerated dose (MTD) or less.
Phase 2: Complete Remission (CR) Rate at the end of Reinduction Block
CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the bone marrow (BM); normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/microliter (μL) (or >1.0 × 10^9 cells/liter [L]); Platelets >100,000/μL (or >100 × 10^9 platelets/L).

Secondary Outcome Measures

Phase 1: CR Rate at the end of Reinduction Block
CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the BM; normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000/μL (or >100 × 10^9 platelets/L).
Phase 2: Percentage of Ph+ ALL Participants or who Achieved CR at the End of Consolidation Block
CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Phase 2: Percentage of Ph+ ALL Participants with Negative Minimal Residual Disease (MRD) Among Those who Achieved CR
MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate at <0.01% threshold.
Phase 2: Percentage of Participants who Relapsed or Progressed Following Reinduction and Consolidation
Phase 2: Event-free Survival (EFS)
EFS is defined as time from date of enrollment until death due to any cause; refractory to treatment (defined as failure to achieve CR by end of the consolidation block) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Phase 2: Progression-free Survival (PFS)
PFS is defined as time from date of enrolment until death related to disease under study; disease progression (clinical deterioration associated with disease process, including evidence of increasing blasts in the bone marrow from baseline and/or evidence of new organ involvement) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Phase 2: Overall Survival (OS)
OS is defined as time from first dose of ponatinib until death due to any cause.
Phase 2: Duration of Response (DOR)
DOR is defined as the interval between the first assessment at which the criteria for CR are met until the time at which relapse from CR occurs. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets /L).
Phase 2: Percentage of Participants who Underwent Hematopoietic Stem Cell Transplantation (HSCT)
Phase 1: Cmax: Maximum Observed Plasma Concentration for Ponatinib
Phase 1: tmax: Time of First Occurrence of Cmax for Ponatinib
Phase 1: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ponatinib
Phase 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Venous Thrombotic/Embolic Events (VTEs), and Adverse Events of Special Interest (AESIs)

Full Information

First Posted
August 4, 2020
Last Updated
October 9, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04501614
Brief Title
A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Official Title
A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
February 27, 2025 (Anticipated)
Study Completion Date
August 27, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment. The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission. Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets or who are receiving less than a 10 mg dose, a capsule with small ponatinib minitablets inside will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.
Detailed Description
The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat pediatric population who have Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), Ph+ mixed phenotype acute leukemia (Ph+ MPAL), or Philadelphia chromosome-like ALL who have relapsed or are resistant or intolerant to a prior tyrosine kinase inhibitor (TKI)-containing therapy, or who have the T315I mutation. The study will enroll approximately 68 participants. Participants will be assigned to a treatment group either in phase 1 or phase 2. Participants unable to swallow the ponatinib tablets or who are receiving less than a 10 mg dose will receive the age-appropriate formulation, capsule with ponatinib minitablets inside: • Ponatinib + Chemotherapy All participants will be asked to take ponatinib once daily. In phase 1 ponatinib will be administered in combination with a chemotherapy backbone to determine the recommended phase 2 dose (RP2D) of ponatinib. In both phase 1 and phase 2, treatment consists of two 35-day blocks of therapy (reinduction block and consolidation block). Each block will include 29 days of treatment of daily ponatinib and a chemotherapy backbone regimen followed by a rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only. This is a multi-center trial and will be conducted worldwide. The overall time to participate in this study is 6.5 years. Participants will make multiple visits to the clinic, and may be contacted by telephone in at least 36 months of follow-up after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL), Philadelphia Chromosome-Like ALL (Ph-like ALL)
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ponatinib
Arm Type
Experimental
Arm Description
Ponatinib tablet or age appropriate formulation (AAF) [i.e., capsules with ponatinib minitablets], based on age and weight, in combination with chemotherapy backbone, orally, once daily in both reinduction block and consolidation block (35 days each including 29 days of treatment followed by rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only) in Phase 1 to determine RP2D. In Phase 2 participants will receive ponatinib at RP2D in combination with chemotherapy backbone.
Intervention Type
Drug
Intervention Name(s)
Ponatinib
Intervention Description
Ponatinib tablets.
Intervention Type
Drug
Intervention Name(s)
Ponatinib AAF
Intervention Description
Ponatinib age appropriate formulation i.e., capsules with ponatinib minitablets.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Agents
Intervention Description
Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), daunorubicin. Agents for intrathecal (IT) chemotherapy, central nervous system (CNS)-1/2: IT methotrexate chemotherapy, or CNS-3: triple intrathecal (ITT) methotrexate, hydrocortisone, cytarabine. Chemotherapy agents for consolidation include dexamethasone, vincristine, methotrexate, PEG-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), cyclophosphamide, etoposide, CNS-1/2: IT methotrexate chemotherapy, CNS-3: ITT chemotherapy methotrexate, hydrocortisone, cytarabine. The doses for chemotherapy agents for reinduction will be given as per standard of care.
Primary Outcome Measure Information:
Title
Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy
Description
The RP2D is the maximum tolerated dose (MTD) or less.
Time Frame
Up to Week 4
Title
Phase 2: Complete Remission (CR) Rate at the end of Reinduction Block
Description
CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the bone marrow (BM); normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/microliter (μL) (or >1.0 × 10^9 cells/liter [L]); Platelets >100,000/μL (or >100 × 10^9 platelets/L).
Time Frame
Up to Week 4
Secondary Outcome Measure Information:
Title
Phase 1: CR Rate at the end of Reinduction Block
Description
CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the BM; normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000/μL (or >100 × 10^9 platelets/L).
Time Frame
Up to Week 4
Title
Phase 2: Percentage of Ph+ ALL Participants or who Achieved CR at the End of Consolidation Block
Description
CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Time Frame
Up to Week 8
Title
Phase 2: Percentage of Ph+ ALL Participants with Negative Minimal Residual Disease (MRD) Among Those who Achieved CR
Description
MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate at <0.01% threshold.
Time Frame
Up to Weeks 4 and 8
Title
Phase 2: Percentage of Participants who Relapsed or Progressed Following Reinduction and Consolidation
Time Frame
Up to Weeks 4 and 8
Title
Phase 2: Event-free Survival (EFS)
Description
EFS is defined as time from date of enrollment until death due to any cause; refractory to treatment (defined as failure to achieve CR by end of the consolidation block) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Time Frame
Up to approximately 36 months
Title
Phase 2: Progression-free Survival (PFS)
Description
PFS is defined as time from date of enrolment until death related to disease under study; disease progression (clinical deterioration associated with disease process, including evidence of increasing blasts in the bone marrow from baseline and/or evidence of new organ involvement) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets/L).
Time Frame
Up to approximately 36 months
Title
Phase 2: Overall Survival (OS)
Description
OS is defined as time from first dose of ponatinib until death due to any cause.
Time Frame
Up to approximately 36 months
Title
Phase 2: Duration of Response (DOR)
Description
DOR is defined as the interval between the first assessment at which the criteria for CR are met until the time at which relapse from CR occurs. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μL (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μL (or >100 × 10^9 platelets /L).
Time Frame
Up to approximately 36 months
Title
Phase 2: Percentage of Participants who Underwent Hematopoietic Stem Cell Transplantation (HSCT)
Time Frame
Up to approximately 36 months
Title
Phase 1: Cmax: Maximum Observed Plasma Concentration for Ponatinib
Time Frame
Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22
Title
Phase 1: tmax: Time of First Occurrence of Cmax for Ponatinib
Time Frame
Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22
Title
Phase 1: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ponatinib
Time Frame
Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22
Title
Phase 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Venous Thrombotic/Embolic Events (VTEs), and Adverse Events of Special Interest (AESIs)
Time Frame
From the first dose of study drug up to 30 days after last dose of study drug (Up to 36 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a diagnosis of Ph+ ALL, Philadelphia chromosome-positive plus mixed phenotype acute leukemia (Ph+ MPAL), or Ph-like ALL with: a) Involvement of BM with ALL, including one of the following: i. M2 BM (5%-24% lymphoblasts): by morphology with confirmatory testing consisting of at least one of the following: flow cytometry lymphoblasts ≥5%, or BCR-ABL1 fluorescence in situ hybridization, or ≥10-2 leukemic clone identified by immunoglobulin heavy chain-T-cell receptor polymerase chain reaction, OR ii. M3 BM (≥25% lymphoblasts): by morphology, OR iii. Participants with combined BM (as defined above) and extramedullary disease. b) Evidence of Ph+ ALL, MPAL, or Ph-like ALL: i. Definite evidence of BCR-ABL1 fusion (Ph) for Ph+ ALL and MPAL, OR ii. Definite evidence of Ph-like ALL with targetable kinase-activating lesions involving any of the following kinase genes: ABL1, ABL2, CSF1R, and PDGFRB. Ph-like ALL diagnosis requires the identification of specified targetable kinase-activating lesions preferably by ribonucleic acid (RNA) sequencing or by alternative accredited method used by the site. c) Disease status: (i) For non-US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a BCR-ABL-targeted tyrosine kinase inhibitor (TKI), or for US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a second-generation BCR-ABL1-targeted TKI (i.e, dasatinib, nilotinib, and bosutinib); OR (ii) Have a BCR-ABL1 T315I mutation irrespective of relapse, resistance/intolerance, or transplant status and irrespective of any prior TKI use. Notes: A participant will be defined as intolerant if they had a Grade ≥3 nonhematologic toxicity or a Grade 4 hematologic toxicity considered related to the last TKI and lasting for >2 weeks, and led to discontinuation of therapy. Weight: Participants must be weighing at least 5 kg at the time of enrollment. Performance Status: Karnofsky performance status ≥50% for participants ≥16 years of age or Lansky Play Scale ≥50% for participants <16 years of age. Have recovered to less than Grade 2 National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0, or to baseline, from any nonhematologic toxicities (except alopecia) due to previous therapy. Participants must meet the following criteria related to prior therapies: Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy. Participants who relapsed while receiving cytotoxic therapy: At least 14 days must have passed since the completion of the last dose of chemotherapy before the first dose of ponatinib can be given except for the following: intrathecal (IT) chemotherapy and/or maintenance therapy such as vincristine, mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance-like therapy. HSCT: Participants who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment. Hematopoietic growth factors: Before the first dose of ponatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days must have passed since completion of therapy with pegfilgrastim. Biologics and targeted therapies: Before the first dose of ponatinib, at least 7 days must have passed since the last dose of a biologic agent. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor's medical monitor/designee. Monoclonal antibodies: After the last dose of monoclonal antibody, at least 3 half-lives of the administered antibody must have passed before the first dose of ponatinib. Immunotherapy: Before the first dose of ponatinib, at least 30 days must have passed after the completion of any type of immunotherapy (eg, tumor vaccines, chimeric antigen receptor T-cell [CAR-T-cell]). Immunosuppressive therapy: Before the first dose of ponatinib, at least 14 days must have passed after the completion of immunosuppressive therapy (including regimens following stem cell transplant). Radiotherapy: No washout period is necessary for radiation given to any extramedullary site other than central nervous system (CNS); ≥90 days must have passed if participant received prior total body irradiation or craniospinal or cranial radiotherapy. Anthracyclines: Participants must have had a lifetime exposure of <400 milligrams per square meter (mg/m^2) of doxorubicin equivalents of anthracyclines. a) Adequate renal function defined as: Estimated glomerular filtration rate (eGFR) using the Schwartz formula, OR radioisotope glomerular filtration rate (GFR)≥70 mL/min/1.73 m^2, OR a normal serum creatinine based on age and sex. b) Adequate liver function defined as: Direct bilirubin ≤1.5 times the upper limit of normal (ULN) for age AND ALT ≤5 times the ULN for age. No clinical, radiological or laboratory evidence of pancreatitis, including: Serum lipase must be <2 times the ULN, AND Serum amylase must be <2 times the ULN. Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by ECHO or multigated acquisition scan (MUGA). Normal QT interval with Fridericia correction method (QTcF) on screening electrocardiogram (ECG), defined as QTcF of ≤450 milliseconds (ms). Exclusion Criteria: A history or current diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia. A history or current diagnosis of chronic myeloid leukemia (CML). Diagnosis of ALL, MPAL, or Ph-like ALL with targetable kinase-activating lesions after treatment with cytotoxic therapy for another cancer. Diagnosis of another concurrent primary malignancy. Clinically significant cardiovascular disease, including but not limited to: Any history of myocardial infarction (MI) or unstable angina. History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias. Uncontrolled hypertension, defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management. Current systemic use of drug(s) that are known to have a risk of causing prolonged corrected QT interval (QTc) or torsades de pointes unless drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system) or the participants can safely discontinue the drug(s). Uncontrolled hypertriglyceridemia (triglycerides ≥450 milligrams per deciliter (mg/dL)). Current systemic use of any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 3A (CYP3A) within 7 days before the first dose of study drug. Previous treatment with ponatinib. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while participant is on study treatment. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption of ponatinib. Participants with deoxyribonucleic acid (DNA) fragility syndromes, such as Fanconi anemia and Bloom syndrome. Participants with Down syndrome. Participants with uncontrolled systemic infection, or known laboratory and/or clinical evidence of active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Participants with pre-existing significant CNS pathology, including history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement, are not eligible. Participants with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. (Participants with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits and causative factor(s) have resolved). Uncontrolled seizure disorder. (Participants with seizure disorders that do not require antiepileptic drugs or are well controlled with stable doses of antiepileptic drugs are eligible). History of severe coagulopathy or cardiovascular or peripheral vascular events. Treatment with live attenuated vaccinations within 30 days prior to initiation of study treatment regimen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
602-933-0920
Email
mhenry@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Michael Henry
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
501-364-3058
Email
kjbielamowicz2@uams.edu
First Name & Middle Initial & Last Name & Degree
Kevin Bielamowicz
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
323-361-4829
Email
andoan@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Andrew Doan
Facility Name
Rady Childrens Hospital San Diego - PIN
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
858-966-5811
Email
vwong@rchsd.org
First Name & Middle Initial & Last Name & Degree
Victor Wong
Facility Name
UCSF Medical Comprehensive Cancer
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
415-541-0853
Email
mignon.loh@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Ben Braun
Facility Name
Alfred I Dupont Hospital For Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
302-651-5584
Email
emi.caywood@nemours.org
First Name & Middle Initial & Last Name & Degree
Emi Caywood
Facility Name
Ann and Robert H Lurie Childrens Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
312-227-4090
Email
jrossoff@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Jenna Rossoff
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
317-944-8784
Email
batras@iu.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Batra
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-632-2313
Email
andrew_place@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Andrew Place
Facility Name
Children's Mercy Hospital and Clinica
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
614-722-3562
Email
kginn@cmh.edu
First Name & Middle Initial & Last Name & Degree
Kevin Ginn
Facility Name
Cincinnati Children's Hospital Medical Center - PIN
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
513-803-1678
Email
maureen.obrien@cchmc.org
First Name & Middle Initial & Last Name & Degree
Maureen O'Brien
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
816-302-6808
Email
mark.ranalli@nationsidechildrens.org
First Name & Middle Initial & Last Name & Degree
Mark Ranalli
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-906-7885
Email
BAILEYC@chop.edu
First Name & Middle Initial & Last Name & Degree
Charles L. Bailey
Facility Name
St Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
901-595-1716
Email
seth.karol@stjude.org
First Name & Middle Initial & Last Name & Degree
Seth Karol
Facility Name
Childrens Medical Center Research Institute at UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
214-456-7000
Email
tamra.slone@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Tamra Slone
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+54 (0) 11-4469-9300
Email
davidveronhonc@gmail.com
First Name & Middle Initial & Last Name & Degree
David Veron
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+54 (0) 11-4959-0348
Email
monica.makiya@hiba.org.ar
First Name & Middle Initial & Last Name & Degree
Monica Leonor Makiya
Facility Name
Queensland Childrens Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61(0)7-3068-1119
Email
chris.fraser@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Christopher Fraser
Facility Name
Royal Children's Hospital Melbourne - PIN
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
61393459184
Email
jordan.hansford@rch.org.au
First Name & Middle Initial & Last Name & Degree
David Hughes
Facility Name
Perth Childrens Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
61893408222
Email
marianne.phillips@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Marianne Phillips
Facility Name
Rua Ramiro Barcelos, 2350
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+55 41 3361-5195
Email
mpianovski@erastinho.com.br
First Name & Middle Initial & Last Name & Degree
Mara Pianovsky
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Du Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+55 51 32148143
Email
pesquisaclinica@santacasa.org.br
First Name & Middle Initial & Last Name & Degree
Camila Voos Soares
Facility Name
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
City
Porto Alegre
State/Province
Rio Grande Du Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
5133598317
Email
ldaudt@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Liane Esteves Daudt
Facility Name
Clinica SUPRA
City
Chapeco
State/Province
Santa Catarina
ZIP/Postal Code
89801-355
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Fundacao Pio XII Hospital de Cancer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
551733216637
Email
brunamancano@gmail.com
First Name & Middle Initial & Last Name & Degree
Bruna Minniti Mancano
Facility Name
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP
City
Ribeirao Preto
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
55 16 39636482
Email
mbergamo@hcrp.usp.br
First Name & Middle Initial & Last Name & Degree
Maristella dos Reis
Facility Name
Graacc Grupo de Apoio Ao Adolescente E A Crianca Com Cancer
City
Sao Paulo
ZIP/Postal Code
04039-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
55 11 50808488
Email
avlsousa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana Virginia Lopes de Sousa
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
55 11 25222472
Email
inctr@inctrbrasil.org
First Name & Middle Initial & Last Name & Degree
Sidnei Epelman
Facility Name
West China Second University Hospital, Sichuan Univesity
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
8613111854621
Email
gaoju651220@126.com
First Name & Middle Initial & Last Name & Degree
Ju Gao
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+86 13983762652
Email
1808106657@qq.com
First Name & Middle Initial & Last Name & Degree
Jie Yu
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
8615180802411
Email
jinjiao999@163.com
First Name & Middle Initial & Last Name & Degree
Jiao Jin
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
8655163869420
Email
zwnltt@126.com
First Name & Middle Initial & Last Name & Degree
Ningling Wang
Facility Name
Qilu Hospital of Shandong University
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
86053182169229
Email
shellysdcn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiu-li Ju
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
ZIP/Postal Code
260003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+86 18661807165
Email
sunlr@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Lirong Sun
Facility Name
Children's Hospital of Shanghai
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
8618917128021
Email
jhui0111@126.com
First Name & Middle Initial & Last Name & Degree
Hui Jiang
Facility Name
Shanghai Childrens Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
8618930830638
Email
shenshuhong@scmc.com.cn
First Name & Middle Initial & Last Name & Degree
Shuhong Shen
Facility Name
Children's Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+86 137 7187 0462
Email
hsy139@126.com
First Name & Middle Initial & Last Name & Degree
Shaoyan Hu
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
xfzhu1981@126.com
First Name & Middle Initial & Last Name & Degree
Xiaofan Zhu
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
jinrunm@qq.com
First Name & Middle Initial & Last Name & Degree
Runming Jin
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+86 18971353983
Email
qunhu2013@163.com
First Name & Middle Initial & Last Name & Degree
Qun Hu
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
61300
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
420532234831
Email
domansky.jiri@fnbrno.cz
First Name & Middle Initial & Last Name & Degree
Jiri Domansky
Facility Name
Fakultni nemocnice v Motole
City
Praha
ZIP/Postal Code
15006
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
420224436400
Email
jan.stary@lfmotol.cuni.cz
First Name & Middle Initial & Last Name & Degree
Jan Star
Facility Name
Hopital Sud
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
33299267162
Email
virginie.gandemer@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Virginie Gandemer
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33 4 91 38 68 19
Email
paul.saultier@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Paul Saultier
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
33140035388
Email
marion.strullu@aphp.fr
First Name & Middle Initial & Last Name & Degree
Marion Strullo
Facility Name
Hopital Des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
33534558611
Email
pasquet.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Marlene Pasquet
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
City
Roma
State/Province
Lazio
ZIP/Postal Code
165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390668592129
Email
franco.locatelli@opbg.net
First Name & Middle Initial & Last Name & Degree
Franco Locatelli
Facility Name
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Concetta Micalizzi
Facility Name
Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390392334915
Email
verix.leo@gmail.com
First Name & Middle Initial & Last Name & Degree
Veronica Leoni
Facility Name
Ospedale Infantile Regina Margherita - INCIPIT - PIN
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+39011 3131865
Email
nbertore@gmail.com
First Name & Middle Initial & Last Name & Degree
Nicoletta Bertorello
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82 2 2072 3304
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82222282060
Email
cj@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Chuhl Joo Lyu
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82-2-3010-7196
Email
hojim@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Ho-Joon Im
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82 2 2258 6188
Email
cngped@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Nack Gyun Chung
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+528183486136
Email
investigacionhematohu@gmail.com
First Name & Middle Initial & Last Name & Degree
Dinorah Catalina Barrera Molina
Facility Name
Instituto Nacional de Pediatria
City
Ciudad De Mexico
ZIP/Postal Code
4530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+525510840912
Email
alberto.olaya@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Alberto Olaya Vargas
Facility Name
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3339424400
Email
hugoromo48@gmail.com
First Name & Middle Initial & Last Name & Degree
Hugo Antonio Romo Rubio
Facility Name
Princess Maxima Center for Pediatric Oncology - PIN
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+31107036691
Email
i.m.vandersluis@prinsesmaximacentrum.nl
First Name & Middle Initial & Last Name & Degree
Inge van der Sluis
Facility Name
Uniwersytecki Szpital Dzieciecy
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48 12 333 92 20
Email
skoczenkr@interia.pl
First Name & Middle Initial & Last Name & Degree
Szymon Skoczen
Facility Name
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48 4261 77750
Email
wojciech.mlynarski@umed.lodz.pl
First Name & Middle Initial & Last Name & Degree
Wojciech Mlynarski
Facility Name
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
48323704372
Email
szczep57@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Tomasz Szczepanski
Facility Name
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
351217229891
Email
jduarte@ipolisboa.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Joaquin Duarte
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
ana.ferreira@ipoporto.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Ana Maia Ferreira
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34934893093
Email
alba.rubio@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Pablo Velasco Puyo
Facility Name
Hospital Infantil Universitario Nino Jesus - PIN
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34915035900 ext 662
Email
alba.rubio@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Alba Rubio San Simon
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
jose.gonzalez.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Jose Gonzalez Campos
Facility Name
Royal Marsden Hospital - Surrey
City
Surrey Quays
State/Province
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+442086613496
Email
donna.lancaster@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Donna Lancaster
Facility Name
Birmingham Childrens Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+441213338712
Email
alice.norton1@nhs.net
First Name & Middle Initial & Last Name & Degree
Alice Norton
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+441865741166
Email
emmy.dickens@nhs.net
First Name & Middle Initial & Last Name & Degree
Emmy Dickens
Facility Name
Royal Hospital for Children (Glasgow) - PPDS - PIN
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+441412010675
Email
brenda.gibson@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Brenda Gibson

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f929169296beb001e63bf5d
Description
Related Info

Learn more about this trial

A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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