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Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia

Primary Purpose

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia With BCR-ABL1

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Blinatumomab
Cyclophosphamide
Cytarabine
Filgrastim
Methotrexate
Pegfilgrastim
Ponatinib
Rituximab
Vincristine
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >= 18 years of age with previously untreated Ph-positive ALL (either t(9;22) and/or BCR-ABL positive) (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.

    • If they achieved CR, they are assessable only for event-free and overall survival, or
    • If they failed to achieve CR, they are assessable for CR, event-free, and overall survival.

Patients >= 18 years of age with relapsed/refractory Ph-positive ALL or lymphoid accelerated or blast phase chronic myelogenous leukemia (CML)

  • Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale)
  • Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) =< 3 x ULN
  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Serum lipase and amylase =< 1.5 x ULN
  • Creatinine =< 2.0 mg/dl
  • Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
  • Adequate cardiac function as assessed clinically by history and physical examination
  • Signed informed consent

Exclusion Criteria:

  • Active serious infection not controlled by oral or intravenous antibiotics
  • Known active hepatitis B. Patients with chronic hepatitis B who are on appropriate viral suppressive therapy may be allowed after discussion with the principal investigator (PI)
  • History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
  • History of alcohol abuse
  • Uncontrolled hypertriglyceridemia
  • Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
  • Active grade III-V cardiac failure as defined by the New York Heart Association criteria
  • Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: myocardial infarction (MI), stroke, or revascularization within 3 months; unstable angina or transient ischemic attack; congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment; diagnosed or suspected congenital long QT syndrome; clinically significant atrial or ventricular arrhythmias as determined by the treating physician; prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement. or approved by cardiologist; Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Patients with a history of treated prior superficial or catheter associated phlebitis will not be considered as significant embolism and after discussion with principal investigator (PI) will not be excluded from eligibility. Uncontrolled hypertension (diastolic blood pressure > 90 mmHg; systolic > 140mmHg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
  • Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days or 5 half-lives before the first dose of ponatinib in patients with newly diagnosed only
  • History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Patients with active CNS leukemia will NOT be excluded
  • Current autoimmune disease or history of autoimmune disease with potential CNS involvement
  • Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
  • Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
  • History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease); and diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemotherapy, ponatinib, blinatumomab)

Arm Description

See Detailed Description.

Outcomes

Primary Outcome Measures

Complete molecular response (CMR) in newly diagnosed Philadelphia chromosome (Ph)-positive and/or BCR-ABL-positive participants
The CMR rate within the first 3 courses for cohort 1 or rate within the first 2 courses for cohort 2 will be estimated along with the 95% credible intervals. Similar analyses will be performed for estimating the rate of complete cytogenetic response and major molecular response rates.
Overall response (OR) in participants with relapsed/refractory acute lymphoblastic leukemia
Overall response is defined as complete response (CR) + complete response with hematologic improvement (CRi) in participants with relapsed/refractory disease.

Secondary Outcome Measures

Complete cytogenetic response
Will be estimated along with the 95% credible intervals.
CMR for relapsed/refractory population
Will be estimated along with the 95% credible intervals.
Event-free survival (EFS)
The Kaplan-Meier method will be used to assess EFS probabilities for each cohort.
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities for each cohort.
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.

Full Information

First Posted
May 5, 2017
Last Updated
October 11, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03147612
Brief Title
Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia
Official Title
Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
February 8, 2024 (Anticipated)
Study Completion Date
February 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

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

5. Study Description

Brief Summary
This phase II trial studies how well low-intensity chemotherapy and ponatinib work in treating patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with rituximab and blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Granulocyte colony stimulating factor helps the bone marrow make recover after treatment. Giving low-intensity chemotherapy, ponatinib, and blinatumomab may work better in treating patients with acute lymphoblastic leukemia.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the complete molecular response (CMR) rate of ponatinib and blinatumomab in combination with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome (Ph)-positive and/or BAR-ABL-positive acute lymphoblastic leukemia (ALL). (Cohort 1) II. To evaluate the overall response (OR; complete response [CR] + complete response with hematologic improvement [CRi]) in patients with relapsed/refractory disease. (Cohort 2) SECONDARY OBJECTIVES: I. To evaluate other clinical efficacy endpoints (complete cytogenetic response, complete molecular response [CMR] [for relapsed/refractory population], event-free survival and overall survival) and safety of the combination regimen. EXPLORATORY OBJECTIVES: I. To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse in patients with Ph+ ALL treated with hyper-CVD plus ponatinib and blinatumomab. II. To determine the impact of recurrent genomic alterations and ribonucleic acid (RNA) expression at diagnosis on relapse free survival (RFS) in patients with Ph+ ALL treated with hyper-CVD plus ponatinib and blinatumomab. III. To investigate the impact of next-generation sequencing-based minimal residual disease assessment on relapse-free survival in patients with Ph+ ALL. IV. To determine the effect on immune cell subsets in patients with Ph+ ALL treated with blinatumomab plus ponatinib. OUTLINE: CYCLES 1 and 3: Patients receive ponatinib orally (PO) once daily (QD) on days 1-21 of cycle 1 and on days 1-28 of subsequent cycles, cyclophosphamide intravenously (IV) twice daily (BID) over 3 hours on days 1-3, rituximab IV over 4-6 hours on days 1 and 11, vincristine IV over 15 minutes on days 1 and 11, and pegfilgrastim or filgrastim subcutaneously (SC) daily on day 4. Patients also receive methotrexate intrathecally via spinal tap on day 2 and cytarabine intrathecally on day 7 in the absence of disease progression or unacceptable toxicity. CYCLES 2 and 4: Patients receive ponatinib PO QD on days 1-28, methotrexate IV over 24 hours on day 1 and intrathecally on day 8, cytarabine IV BID over 2-3 hours on days 2 and 3 and intrathecally on day 5, pegfilgrastim or filgrastim SC daily on day 4, and rituximab IV over 4-6 hours on days 1 and 8 in the absence of disease progression or unacceptable toxicity. CYCLES 5-8: Patients receive blinatumomab via central catheter continuously over weeks 1-4 every 6 weeks. Patients also receive methotrexate intrathecally on day 1 of cycle 5 and on day 8 of cycle 6 and cytarabine intrathecally on day 7 of cycle 5 and on day 1 of cycle 6 in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: CYCLES 1-3, 5-7, 9-11, and 13-15: After 4 cycles of blinatumomab, if disease has not gotten worse, patients receive vincristine IV over 15 minutes on day 1, prednisone PO on days 1-5, and ponatinib PO QD on days 1-28. CYCLES 4, 8, and 12: Patients receive blinatumomab via central catheter continuously over weeks 1-4 every 6 weeks and ponatinib PO QD on days 1-28. Treatment repeats every 28 days for up to 15 cycles in the absence of disease progression or unacceptable toxicity. Patients unable to receive blinatumomab, you may receive maintenance therapy with vincristine, prednisone, and ponatinib for a total of about 24 cycles at the discretion of doctor. POST-MAINTENANCE THERAPY: Patients receive ponatinib PO QD on days 1-28. Cycles repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia With BCR-ABL1, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemotherapy, ponatinib, blinatumomab)
Arm Type
Experimental
Arm Description
See Detailed Description.
Intervention Type
Biological
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI-538, MT-103
Intervention Description
Given via central catheter
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
.beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
Intervention Description
Given intrathecally or IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim-aafi, G-CSF, Neupogen, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tevagrastim
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
Intervention Description
Given intrathecally or IV
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, Fulphila, HSP-130, Jinyouli, Neulasta, Neulastim, Nyvepria, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, Pegfilgrastim-jmdb, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Ponatinib
Other Intervention Name(s)
AP-24534, AP24534
Intervention Description
Given PO
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Leurocristine, VCR, Vincrystine
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Complete molecular response (CMR) in newly diagnosed Philadelphia chromosome (Ph)-positive and/or BCR-ABL-positive participants
Description
The CMR rate within the first 3 courses for cohort 1 or rate within the first 2 courses for cohort 2 will be estimated along with the 95% credible intervals. Similar analyses will be performed for estimating the rate of complete cytogenetic response and major molecular response rates.
Time Frame
Up to 84 days (3 courses)
Title
Overall response (OR) in participants with relapsed/refractory acute lymphoblastic leukemia
Description
Overall response is defined as complete response (CR) + complete response with hematologic improvement (CRi) in participants with relapsed/refractory disease.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Complete cytogenetic response
Description
Will be estimated along with the 95% credible intervals.
Time Frame
Up to 6 years
Title
CMR for relapsed/refractory population
Description
Will be estimated along with the 95% credible intervals.
Time Frame
Up to 6 years
Title
Event-free survival (EFS)
Description
The Kaplan-Meier method will be used to assess EFS probabilities for each cohort.
Time Frame
From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 6 years
Title
Overall survival (OS)
Description
The Kaplan-Meier method will be used to assess OS probabilities for each cohort.
Time Frame
From the first day of treatment to time of death from any cause, assessed up to 6 years
Title
Incidence of adverse events (AEs)
Description
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >= 18 years of age with previously untreated Ph-positive ALL (either t(9;22) and/or BCR-ABL positive) (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible. If they achieved CR, they are assessable only for event-free and overall survival, or If they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients >= 18 years of age with relapsed/refractory Ph-positive ALL or lymphoid accelerated or blast phase chronic myelogenous leukemia (CML) Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale) Total serum bilirubin =< 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome Alanine aminotransferase (ALT) =< 3 x ULN Aspartate aminotransferase (AST) =< 3 x ULN Serum lipase and amylase =< 1.5 x ULN Creatinine =< 2.0 mg/dl Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse Adequate cardiac function as assessed clinically by history and physical examination Signed informed consent Exclusion Criteria: Active serious infection not controlled by oral or intravenous antibiotics Known active hepatitis B. Patients with chronic hepatitis B who are on appropriate viral suppressive therapy may be allowed after discussion with the principal investigator (PI) History of acute pancreatitis within 1 year of study or history of chronic pancreatitis History of alcohol abuse Uncontrolled hypertriglyceridemia Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year Active grade III-V cardiac failure as defined by the New York Heart Association criteria Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: myocardial infarction (MI), stroke, or revascularization within 3 months; unstable angina or transient ischemic attack; congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment; diagnosed or suspected congenital long QT syndrome; clinically significant atrial or ventricular arrhythmias as determined by the treating physician; prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement. or approved by cardiologist; Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Patients with a history of treated prior superficial or catheter associated phlebitis will not be considered as significant embolism and after discussion with principal investigator (PI) will not be excluded from eligibility. Uncontrolled hypertension (diastolic blood pressure > 90 mmHg; systolic > 140mmHg). Patients with hypertension should be under treatment on study entry to effect blood pressure control Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days or 5 half-lives before the first dose of ponatinib in patients with newly diagnosed only History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Patients with active CNS leukemia will NOT be excluded Current autoimmune disease or history of autoimmune disease with potential CNS involvement Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease); and diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Jabbour
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias Jabbour
Phone
713-792-4764
Email
ejabbour@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Elias Jabbour

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia

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