Back to resultsStudy of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA)
Primary Purpose
B-Cell Acute Lymphoblastic Leukemia
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CTL019
Sponsored by
About this trial
This is an interventional treatment trial for B-Cell Acute Lymphoblastic Leukemia focused on measuring CTL019, Kymriah, B-Cell Acute Lymphoblastic Leukemia, ALL, tisagenlecleucel, HR B-ALL EOC MRD, Minimal Residual Disease (MRD), Positive at the End of Consolidation (EOC)
Eligibility Criteria
Inclusion Criteria:
- CD19 expressing B-cell Acute Lymphoblastic Leukemia
- De novo NCI HR B-ALL who received first-line treatment and are MRD ≥ 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
- Age 1 to 25 years at the time of screening
- Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
Adequate organ function during the screening period:
A. Renal function based on age/gender B. ALT ≤ 5 times ULN for age C. AST ≤ 5 times ULN for age D. Total bilirubin < 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin < 4 mg/dL)
E. Adequate pulmonary function defined as:
- no or mild dyspnea (≤ Grade 1)
- oxygen saturation of > 90% on room air F. Adequate cardiac function defined as LVSF ≥ 28% confirmed by echocardiogram or LVEF ≥ 45% confirmed by echocardiogram or MUGA within 6 weeks of screening
- Prior induction and consolidation chemotherapy allowed: 1st line subjects: ≤ 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate.
Exclusion Criteria:
- M3 marrow at the completion of 1st line induction therapy
- M2 or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy or evidence of disease progression in the peripheral blood or new extramedullary disease prior to enrollment. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of screening.
- Philadelphia chromosome positive ALL
- Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
- Prior tyrosine kinase inhibitor therapy
- Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Subjects with Down syndrome will not be excluded.
- Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
- Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy
Other protocol-defined inclusion/exclusion may apply.
Sites / Locations
- Children s Hospital of AlabamaRecruiting
- Phoenix Children's HospitalRecruiting
- City of Hope National MedicalRecruiting
- Childrens Hospital Los Angeles SC CTL019Recruiting
- Mattel Childrens Hospital UCLARecruiting
- Children's Hospital of Orange County CHOC Children'sRecruiting
- Rady Children s Hospital CTBM100C2401Recruiting
- UCSF Medical Center .Recruiting
- Stanford Universtiy Medical Center .Recruiting
- Childrens Hospital ColoradoRecruiting
- Yale School of MedicineRecruiting
- Childrens National HospitalRecruiting
- Johns Hopkins All childrensRecruiting
- Children's Healthcare of Atlanta Emory University IRBRecruiting
- Ann and Robert H Lurie Childrens Hospital of ChicagoRecruiting
- University of ChicagoRecruiting
- James Whitcomb Riley Hospital for ChildrenRecruiting
- Norton Children s HospitalRecruiting
- Johns Hopkins Oncology Center Cancer Research BuildingRecruiting
- Dana Farber Cancer Institute Dept.of DFCIRecruiting
- University of MichiganRecruiting
- University of Minnesota CAEB071B2201Recruiting
- University of Mississippi Medical Center Childrens Hospital .Recruiting
- Children s Mercy HospitalRecruiting
- St. Louis University/Cardinal Glennon Children's HospitalRecruiting
- Washington University CTBM100C2412Recruiting
- University of Nebraska Medical CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Cohen Children's Medical Center of New York
- Memorial Sloan Kettering Cancer CenterRecruiting
- Columbia University Medical Center OncologyRecruiting
- Duke University Medical Center .Recruiting
- Cinn Children Hosp Medical CenterRecruiting
- Univ Hospital - Cleveland/Rainbow Babies and Children's Hosp Pediatric NephrologyRecruiting
- Cleveland ClinicRecruiting
- Nationwide Childrens Hospital suite T6BRecruiting
- Oregon Health and Science University .Recruiting
- Penn State Childrens HospitalRecruiting
- The Childrens Hospital of Philadelphia Div Gastroint., Hepat. & Nutr.Recruiting
- Medical Uni of South Carolina Medical Univ of SCRecruiting
- Monroe Carell Jr Childrens Hospital at VanderbiltRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Texas Children's Cancer and Hematology CenterRecruiting
- Methodist Children's Hospital .Recruiting
- University of Utah Clinical Trials Office .Recruiting
- Children's Hospital of Richmond at VCU Pediatric Hematology OncologyRecruiting
- University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping AddressRecruiting
- Childrens Hospital of WisconsinRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Prinses Maxima Centrum voor KinderoncologieRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single dose of CTL019
Arm Description
Based on the subject's weight one of two possible dose ranges will be prepared for the subject: Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight OR Subjects > 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
Outcomes
Primary Outcome Measures
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause.
Overall Survival (OS) rate
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
Secondary Outcome Measures
Percentage of participants who are disease free without allogeneic stem cell transplant (SCT)
Minimal Residual Disease (MRD) negative remission (complete remission (CR) or Complete remission with incomplete blood count recovery CRi)) at Month 12 without SCT after tisagenlecleucel infusion.
DFS rate with censoring for new anticancer therapy, including SCT, while in remission
Assessing the effect of tisagenlecleucel on DFS if new anticancer therapy is not available.
Percentage of participants achieving MRD negative CR or CRi at Month 3
Assessing the percentage of participants who achieved MRD negative complete response (CR) or Complete remission with incomplete blood count recovery (CRi) status as determined by central laboratory using multi-parameter flow cytometry.
Percentage of participants with in CR or CRi with persistent B-cell aplasia over time post tisagenlecleucel infusion
Absolute lymphocyte CD19 count of <50/uL
Percentage of participants who have tisagenlecleucel product successfully manufactured over the total number of subjects enrolled for the age ≥1 year and < 3 years
Success in manufacturing of tisagenlecleucel dose for patients who are ≥1 year and <3 years as respective time points.
Pediatric Quality of Life (PedsQL)
Patient reported outcome to assess quality of life in patients aged 8 and above. The 23 items PedQL (Pediatrics Quality of Life Inventory) measure core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning.
Items measured include 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items).
Each item is measured on a 5 point Likert scale with 0 indicating "never" and 4 indicating "almost always".
The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life (HRQoL).
European Quality of Life 5 dimensions (EQ-5D-3L & EQ-5D-Y))
Patient reported outcome to assess health status in patients aged 8 and above. The EQ-5D (European Quality of Life -5 Dimensions) measures a wide range of health conditions and treatments; it is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (EQ-visual analogue scale [EQ-VAS]) that records the patient's self-rated overall health state.
Respondents rate each of these 5 dimensions from "no problem", "some problem," or "extreme problem".
The EQ-VAS records the respondents' self-related health on a vertical, visual analogue scale. The range for EQ-VAS is from 0 (=the worst health you can imagine) to 100 (=the best health you can imagine).
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Detection test
Speed of performance (mean of the log10 transformed reaction times for correct responses)
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: Identification test
This test measures the speed of performance (mean of the log10 transformed reaction times for correct responses)
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Groton Maze Learning test
This test looks at the total number of errors made in attempting to learn the hidden pathways during a single session.
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: One Back test
This test measures the accuracy of performance (arcsine transformation of the square root of the percentage of correct responses). The test also measures the speed of performance (mean of the log10 transformed reaction times for correct responses).
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: One card learning test
This test measures the accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).
Percentage of participants with pre-existing antibodies
Prevalence of immunogenicity
Percentage of participants with anti-m CAR19 antibodies post infusion with tisagenlecleucel and % of patients without measureable anti-mCAR19 antibodies
Incidence of immunogenicity
Percentage of patients that have measureable anti-mCAR19 antibodies above patient specific cut-point (reported as a %) pre and post tisagenlecleucel infusion categorized by Day 28 response
Impact of immunogenicity on clinical response
tisagenlecleucel transgene concentration
Transgene concentration as detected by qPCR in target tissue
Expression of tisagenlecleucel
Summary of tisagenlecleucel CAR-positive viable T cells measured by flow cytometry in target tissue
Persistence of CAR (reported as copies/ug) categorized by the time to B-cell recovery (recovery < 3 months, >3 months to < 6months, > 6 months)
Relationship between B-cell recovery and transgene levels
Cmax; cellular kinetic parameter of tisagenlecleucel
The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
Tmax; cellular kinetic parameter of tisagenlecleucel
The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
The AUC from time zero to day 29 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days )
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
The AUC from time zero to Tmax in peripheral blood (% or copies/μg x days)
T1/2; cellular kinetic parameter of tisagenlecleucel
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Clast; cellular kinetic parameter of tisagenlecleucel
The last observed quantifiable concentration in peripheral blood (% or copies/μg)
Tlast; cellular kinetic parameter of tisagenlecleucel
The time of last observed quantifiable concentration in peripheral blood (days)
Impact of tisagenlecleucel dose on day 29 response
Clinical response summarized by quartile of administered doses
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The AUC from time zero to day 29 in peripheral blood (% or copies/μg x days )
Cmax: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
Tmax: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
T1/2: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Full Information
NCT ID
NCT03876769
First Posted
November 12, 2018
Last Updated
September 11, 2023
Sponsor
Novartis Pharmaceuticals
Collaborators
Children's Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT03876769
Brief Title
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
Acronym
CASSIOPEIA
Official Title
A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
October 19, 2027 (Anticipated)
Study Completion Date
October 19, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Children's Oncology Group
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 is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Acute Lymphoblastic Leukemia
Keywords
CTL019, Kymriah, B-Cell Acute Lymphoblastic Leukemia, ALL, tisagenlecleucel, HR B-ALL EOC MRD, Minimal Residual Disease (MRD), Positive at the End of Consolidation (EOC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single dose of CTL019
Arm Type
Experimental
Arm Description
Based on the subject's weight one of two possible dose ranges will be prepared for the subject:
Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight
OR
Subjects > 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
Intervention Type
Biological
Intervention Name(s)
CTL019
Intervention Description
Based on the subject's weight, one of two possible dose ranges will be prepared for the subject:
Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight
OR
Subjects > 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
Description
DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause.
Time Frame
5 years after tisagenlecleucel infusion
Title
Overall Survival (OS) rate
Description
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
Time Frame
4 years after tisagenlecleucel
Secondary Outcome Measure Information:
Title
Percentage of participants who are disease free without allogeneic stem cell transplant (SCT)
Description
Minimal Residual Disease (MRD) negative remission (complete remission (CR) or Complete remission with incomplete blood count recovery CRi)) at Month 12 without SCT after tisagenlecleucel infusion.
Time Frame
12 months after last infusion
Title
DFS rate with censoring for new anticancer therapy, including SCT, while in remission
Description
Assessing the effect of tisagenlecleucel on DFS if new anticancer therapy is not available.
Time Frame
5 years
Title
Percentage of participants achieving MRD negative CR or CRi at Month 3
Description
Assessing the percentage of participants who achieved MRD negative complete response (CR) or Complete remission with incomplete blood count recovery (CRi) status as determined by central laboratory using multi-parameter flow cytometry.
Time Frame
3 months after the tisagenlecleucel infusion.
Title
Percentage of participants with in CR or CRi with persistent B-cell aplasia over time post tisagenlecleucel infusion
Description
Absolute lymphocyte CD19 count of <50/uL
Time Frame
8 years
Title
Percentage of participants who have tisagenlecleucel product successfully manufactured over the total number of subjects enrolled for the age ≥1 year and < 3 years
Description
Success in manufacturing of tisagenlecleucel dose for patients who are ≥1 year and <3 years as respective time points.
Time Frame
8 years
Title
Pediatric Quality of Life (PedsQL)
Description
Patient reported outcome to assess quality of life in patients aged 8 and above. The 23 items PedQL (Pediatrics Quality of Life Inventory) measure core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning.
Items measured include 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items).
Each item is measured on a 5 point Likert scale with 0 indicating "never" and 4 indicating "almost always".
The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life (HRQoL).
Time Frame
5 years
Title
European Quality of Life 5 dimensions (EQ-5D-3L & EQ-5D-Y))
Description
Patient reported outcome to assess health status in patients aged 8 and above. The EQ-5D (European Quality of Life -5 Dimensions) measures a wide range of health conditions and treatments; it is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (EQ-visual analogue scale [EQ-VAS]) that records the patient's self-rated overall health state.
Respondents rate each of these 5 dimensions from "no problem", "some problem," or "extreme problem".
The EQ-VAS records the respondents' self-related health on a vertical, visual analogue scale. The range for EQ-VAS is from 0 (=the worst health you can imagine) to 100 (=the best health you can imagine).
Time Frame
5 years
Title
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Detection test
Description
Speed of performance (mean of the log10 transformed reaction times for correct responses)
Time Frame
5 years
Title
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: Identification test
Description
This test measures the speed of performance (mean of the log10 transformed reaction times for correct responses)
Time Frame
5 years
Title
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Groton Maze Learning test
Description
This test looks at the total number of errors made in attempting to learn the hidden pathways during a single session.
Time Frame
5 years
Title
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: One Back test
Description
This test measures the accuracy of performance (arcsine transformation of the square root of the percentage of correct responses). The test also measures the speed of performance (mean of the log10 transformed reaction times for correct responses).
Time Frame
5 years
Title
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: One card learning test
Description
This test measures the accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).
Time Frame
5 years
Title
Percentage of participants with pre-existing antibodies
Description
Prevalence of immunogenicity
Time Frame
8 years
Title
Percentage of participants with anti-m CAR19 antibodies post infusion with tisagenlecleucel and % of patients without measureable anti-mCAR19 antibodies
Description
Incidence of immunogenicity
Time Frame
8 years
Title
Percentage of patients that have measureable anti-mCAR19 antibodies above patient specific cut-point (reported as a %) pre and post tisagenlecleucel infusion categorized by Day 28 response
Description
Impact of immunogenicity on clinical response
Time Frame
8 years
Title
tisagenlecleucel transgene concentration
Description
Transgene concentration as detected by qPCR in target tissue
Time Frame
8 years
Title
Expression of tisagenlecleucel
Description
Summary of tisagenlecleucel CAR-positive viable T cells measured by flow cytometry in target tissue
Time Frame
8 years
Title
Persistence of CAR (reported as copies/ug) categorized by the time to B-cell recovery (recovery < 3 months, >3 months to < 6months, > 6 months)
Description
Relationship between B-cell recovery and transgene levels
Time Frame
8 years
Title
Cmax; cellular kinetic parameter of tisagenlecleucel
Description
The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
Time Frame
8 years
Title
Tmax; cellular kinetic parameter of tisagenlecleucel
Description
The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Time Frame
8 years
Title
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
Description
The AUC from time zero to day 29 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days )
Time Frame
8 years
Title
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
Description
The AUC from time zero to Tmax in peripheral blood (% or copies/μg x days)
Time Frame
8 years
Title
T1/2; cellular kinetic parameter of tisagenlecleucel
Description
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Time Frame
8 years
Title
Clast; cellular kinetic parameter of tisagenlecleucel
Description
The last observed quantifiable concentration in peripheral blood (% or copies/μg)
Time Frame
8 years
Title
Tlast; cellular kinetic parameter of tisagenlecleucel
Description
The time of last observed quantifiable concentration in peripheral blood (days)
Time Frame
8 years
Title
Impact of tisagenlecleucel dose on day 29 response
Description
Clinical response summarized by quartile of administered doses
Time Frame
8 years
Title
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
Description
Impact of tisagenlecleucel exposure on day 29 response; The AUC from time zero to day 29 in peripheral blood (% or copies/μg x days )
Time Frame
Day 29
Title
Cmax: cellular kinetic parameter of tisagenlecleucel
Description
Impact of tisagenlecleucel exposure on day 29 response; The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
Time Frame
Day 29
Title
Tmax: cellular kinetic parameter of tisagenlecleucel
Description
Impact of tisagenlecleucel exposure on day 29 response; The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Time Frame
Day 29
Title
T1/2: cellular kinetic parameter of tisagenlecleucel
Description
Impact of tisagenlecleucel exposure on day 29 response; The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Time Frame
Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CD19 expressing B-cell Acute Lymphoblastic Leukemia
De novo NCI HR B-ALL who received first-line treatment and are MRD ≥ 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
Age 1 to 25 years at the time of screening
Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
Adequate organ function during the screening period:
A. Renal function based on age/gender B. ALT ≤ 5 times ULN for age C. AST ≤ 5 times ULN for age D. Total bilirubin < 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin < 4 mg/dL)
E. Adequate pulmonary function defined as:
no or mild dyspnea (≤ Grade 1)
oxygen saturation of > 90% on room air F. Adequate cardiac function defined as LVSF ≥ 28% confirmed by echocardiogram or LVEF ≥ 45% confirmed by echocardiogram or MUGA within 6 weeks of screening
Prior induction and consolidation chemotherapy allowed: 1st line subjects: ≤ 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate.
Exclusion Criteria:
M3 marrow at the completion of 1st line induction therapy
M2 or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy or evidence of disease progression in the peripheral blood or new extramedullary disease prior to enrollment. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of screening.
Philadelphia chromosome positive ALL
Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
Prior tyrosine kinase inhibitor therapy
Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Subjects with Down syndrome will not be excluded.
Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy
Other protocol-defined inclusion/exclusion may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Children s Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Quinn
Email
Colleen.Quinn@childrensal.org
First Name & Middle Initial & Last Name & Degree
Matthew Kutny
Facility Name
Phoenix Children's 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
Dresden Whitehead
Phone
602-546-0985
Email
dwhitehead@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Dana Salzberg
Facility Name
City of Hope National Medical
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
+16262564673#85013
First Name & Middle Initial & Last Name & Degree
Anna Pawlowska
Facility Name
Childrens Hospital Los Angeles SC CTL019
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
Lee Chen
Phone
323-361-8670
Email
lchen@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Emily Hsieh
Facility Name
Mattel Childrens Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunice Kim
Email
EMKim@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Satiro De Oliveira
Facility Name
Children's Hospital of Orange County CHOC Children's
City
Orange
State/Province
California
ZIP/Postal Code
92868-3874
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lissamarie Donjuan
Email
Lissamarie.Donjuan@choc.org
First Name & Middle Initial & Last Name & Degree
Van Huynh
Facility Name
Rady Children s Hospital CTBM100C2401
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
Sheila Medina-Torne
Phone
858-966-8153
Email
smedinatorne@rchsd.org
First Name & Middle Initial & Last Name & Degree
Deborah Schiff
Facility Name
UCSF Medical Center .
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
Emily Theobald
Phone
415-353-1351
Email
emily.theobald@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Michelle Hermiston
Facility Name
Stanford Universtiy Medical Center .
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandria Lim
Phone
650-723-4000
Email
alexlim@stanford.edu
First Name & Middle Initial & Last Name & Degree
Kara Davis
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Telang
Phone
720-777-5379
Email
Jayratna.Telang@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Kelly Maloney
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Galarza
Email
Brittany.Galarza@yale.edu
First Name & Middle Initial & Last Name & Degree
Aron Flagg
Facility Name
Childrens National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzie Goodick
Phone
202-476-5000
Email
mgoodick@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Reuven L Schore
Facility Name
Johns Hopkins All childrens
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Snyder
Email
ISnyder5@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Deepakbabu Chellapandian
Facility Name
Children's Healthcare of Atlanta Emory University IRB
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Votaw
Email
Sarah.Votaw@choa.org
First Name & Middle Initial & Last Name & Degree
Muna Qayed
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
Monica Newmark
Phone
312-227-4811
Email
mnewmark@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Sonali Chaudhury
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Labelle
Facility Name
James Whitcomb 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
Jennifer Pencek
Phone
317-274-4281
Email
jpencek@iupui.edu
First Name & Middle Initial & Last Name & Degree
April Rahrig
Facility Name
Norton Children s Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Tse
Facility Name
Johns Hopkins Oncology Center Cancer Research Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genevieve Courpas
Phone
410-502-5940
Email
Gcourpa1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Stacy Cooper
Facility Name
Dana Farber Cancer Institute Dept.of DFCI
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatou Dieng
Email
fatou_dieng@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Andrew Place
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2800
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dustin Walling
Phone
734-936-8538
Email
dustinwa@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Rajen Mody
Facility Name
University of Minnesota CAEB071B2201
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mollie Koppes
Phone
612-273-6212
Email
thom1031@umn.edu
First Name & Middle Initial & Last Name & Degree
Peter Gordon
Facility Name
University of Mississippi Medical Center Childrens Hospital .
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andy Collier
Facility Name
Children s Mercy Hospital
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
Robin Ryan
Phone
816-234-3977
Email
rryan@cmh.edu
First Name & Middle Initial & Last Name & Degree
Gary D. Myers
Facility Name
St. Louis University/Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Marin
Phone
314-577-5608
Email
Donna.marin@health.slu.edu
First Name & Middle Initial & Last Name & Degree
William Ferguson
Facility Name
Washington University CTBM100C2412
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Gibson
Phone
314-454-2253
Email
k.gibson@wustl.edu
First Name & Middle Initial & Last Name & Degree
Thomas Pfeiffer
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Holcomb
Phone
402-559-4000
Email
sholcomb@unmc.edu
First Name & Middle Initial & Last Name & Degree
Don Coulter
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Jack Ricourt
Phone
+1 201 996 2000
Email
andrea.ricourt@hmhn.org
First Name & Middle Initial & Last Name & Degree
Alfred Gillio
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Schechter
Phone
716-845-4485
Email
danielle.schechter@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Clare Twist
Facility Name
Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Shteynberg
Phone
212-639-3112
Email
shteyne@mskcc.org
First Name & Middle Initial & Last Name & Degree
Kevin Curran
Facility Name
Columbia University Medical Center Oncology
City
New York
State/Province
New York
ZIP/Postal Code
110032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Stein
Email
djs2245@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Prakash Satwani
Facility Name
Duke University Medical Center .
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Phifer
Phone
919-681-6898
Email
Eileen.phifer@duke.edu
First Name & Middle Initial & Last Name & Degree
Timothy A Driscoll
Facility Name
Cinn Children Hosp Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Nelson
Phone
800-344-2462
Email
adam.nelson@cchmc.org
First Name & Middle Initial & Last Name & Degree
Christine Phillips
Facility Name
Univ Hospital - Cleveland/Rainbow Babies and Children's Hosp Pediatric Nephrology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoinette Hillian
Phone
218-844-3681
Email
Antoinette.Hillian@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Duncan Stearns
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Previte
Phone
216-442-5232
Email
PREVITN@ccf.org
First Name & Middle Initial & Last Name & Degree
Rabi Hanna
Facility Name
Nationwide Childrens Hospital suite T6B
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
Trittnee Robinson
Phone
614-722-2556
Email
Trittnee.Robinson@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Mark Ranalli
Facility Name
Oregon Health and Science University .
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nycole Ferguson
Phone
503-494-5893
Email
ferguson@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Bill Chang
Facility Name
Penn State Childrens Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christinia Crnjar
Phone
717-531-6955
Email
ccrnjar@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Robert Greiner
Facility Name
The Childrens Hospital of Philadelphia Div Gastroint., Hepat. & Nutr.
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
Katherine S. Lopez
Phone
215-590-2985
Email
lopezk3@chop.edu
First Name & Middle Initial & Last Name & Degree
Shannon Maude
Facility Name
Medical Uni of South Carolina Medical Univ of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Smith
Phone
843-876-8614
Email
smithmj@musc.edu
First Name & Middle Initial & Last Name & Degree
Michelle Hudspeth
Facility Name
Monroe Carell Jr Childrens Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenia Owens
Phone
615-321-5247
Email
eugenia.owens@vumc.org
First Name & Middle Initial & Last Name & Degree
Carrie Kitko
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Black
Phone
214-648-1390
Email
mariah.black@childrens.com
First Name & Middle Initial & Last Name & Degree
Samuel John
Facility Name
Texas Children's Cancer and Hematology 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
Cara-Lee Fontaine
Phone
832-824-1000
Email
clfontai@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
Rayne Rouce
Facility Name
Methodist Children's Hospital .
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark De Hoyos
Email
mark.hoyos@mhshealth.com
First Name & Middle Initial & Last Name & Degree
Amanda Lipsitt
Facility Name
University of Utah Clinical Trials Office .
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Best
Phone
801-587-5711
Email
Keeley.Best@imail2.org
First Name & Middle Initial & Last Name & Degree
Luke Maese
Facility Name
Children's Hospital of Richmond at VCU Pediatric Hematology Oncology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Garren
Phone
804-828-9605
Email
garreng@vcu.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Krieger
Facility Name
University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Weiland
Email
PedsHemOncResearch@lists.wisc.edu
First Name & Middle Initial & Last Name & Degree
Christian Capitini
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Murphy
Email
tmurphy@childrenswi.org
First Name & Middle Initial & Last Name & Degree
Julie-An Talano
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prinses Maxima Centrum voor Kinderoncologie
City
Utrecht
State/Province
CS
ZIP/Postal Code
3584
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Pieters
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Goteborg
ZIP/Postal Code
SE 416 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Citations:
PubMed Identifier
32589970
Citation
Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.
Results Reference
derived
Learn more about this trial
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
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