Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA)

March 22, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Active, not recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, 2100
        • Active, not recruiting
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00029
        • Withdrawn
        • Novartis Investigative Site
  • France
      • Paris, France, 75019
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Frankfurt, Germany, 60590
        • Withdrawn
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Withdrawn
        • Novartis Investigative Site
      • Muenchen, Germany, 81377
        • Withdrawn
        • Novartis Investigative Site
  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
    • CS
      • Utrecht, CS, Netherlands, 3584
        • Recruiting
        • Prinses Maxima Centrum voor Kinderoncologie
        • Principal Investigator:
          • R. Pieters
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Novartis Investigative Site
  • Spain
    • Barcelona
      • Esplugues De Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden, SE 416 85
        • Recruiting
        • Novartis Investigative Site
      • Stockholm, Sweden, 141 86
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, WC1E 6HX
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
        • Principal Investigator:
          • Dana Salzberg
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical
        • Principal Investigator:
          • Anna Pawlowska
        • Contact:
          • Phone Number: +16262564673#85013
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Childrens Hospital Los Angeles SC CTL019
        • Contact:
        • Principal Investigator:
          • Emily Hsieh
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mattel Childrens Hospital UCLA
        • Contact:
        • Principal Investigator:
          • Satiro De Oliveira
      • Orange, California, United States, 92868-3874
        • Recruiting
        • Childrens Hospital of Orange County CHOC Children's
        • Principal Investigator:
          • Van Huynh
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children s Hospital CTBM100C2401
        • Principal Investigator:
          • Deborah Schiff
        • Contact:
          • Phone Number: 858-966-8153
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center .
        • Contact:
        • Principal Investigator:
          • Michelle Hermiston
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center .
        • Principal Investigator:
          • Kara Davis
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital Colorado .
        • Principal Investigator:
          • Kelly Maloney
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale School of Medicine
        • Principal Investigator:
          • Aron Flagg
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Childrens National Hospital
        • Contact:
          • Phone Number: 202-476-5000
        • Principal Investigator:
          • Reuven Schore
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Childrens
        • Principal Investigator:
          • Deepakbabu Chellapandian
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Healthcare of Atlanta Emory University IRB
        • Contact:
        • Principal Investigator:
          • Muna Qayed
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Childrens Hospital of Chicago .
        • Principal Investigator:
          • Sonali Chaudhury
        • Contact:
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Hospital .
        • Principal Investigator:
          • James Labelle
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • James Whitcomb Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • April Rahrig
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Withdrawn
        • Norton Children s Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Active, not recruiting
        • Johns Hopkins Oncology Center Cancer Research Building
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana Farber Cancer Institute Dept.of DFCI
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • Recruiting
        • University of Michigan
        • Contact:
          • Phone Number: 734-936-8538
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota CAEB071B2201
        • Contact:
        • Principal Investigator:
          • Peter Gordon
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Withdrawn
        • University of Mississippi Medical Center Childrens Hospital .
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Active, not recruiting
        • Children s Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington Univ School of Medicine CTBM100C2412
        • Principal Investigator:
          • Thomas Pfeiffer
        • Contact:
      • Saint Louis, Missouri, United States, 63104
        • Withdrawn
        • St. Louis University/Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Hackensack Univ Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute Main Centre
        • Principal Investigator:
          • Clare Twist
        • Contact:
          • Phone Number: 716-845-4485
      • New Hyde Park, New York, United States, 11040
        • Withdrawn
        • Cohen Children's Medical Center of New York
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Memorial Sloan Kettering Cancer Ctr .
      • New York, New York, United States, 110032
        • Active, not recruiting
        • Columbia University Medical Center Oncology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center .
        • Contact:
        • Principal Investigator:
          • Timothy A Driscoll
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Cinn Children Hosp Medical Center
        • Contact:
        • Principal Investigator:
          • Christine Phillips
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Univ Hospital - Cleveland/Rainbow Babies and Children's Hosp Pediatric Nephrology
        • Principal Investigator:
          • Duncan Stearns
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation Main Centre
        • Contact:
        • Principal Investigator:
          • Rabi Hanna
      • Columbus, Ohio, United States, 43205
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Recruiting
        • Oregon Health and Science University .
        • Contact:
        • Principal Investigator:
          • Bill Chang
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Withdrawn
        • Penn State Childrens Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Childrens Hosp of Philadelphia Div Gastroint., Hepat. & Nutr.
        • Principal Investigator:
          • Shannon Maude
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical Uni of South Carolina Medical Univ of SC
        • Contact:
        • Principal Investigator:
          • Michelle Hudspeth
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Monroe Carell Jr Childrens Hospital at Vanderbilt
        • Principal Investigator:
          • Carrie Kitko
        • Contact:
          • Phone Number: 615-321-5247
    • Texas
      • Dallas, Texas, United States, 75390-9034
        • Recruiting
        • Univ of Texas Southwest Med Center
        • Principal Investigator:
          • Samuel John
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Cancer and Hematology Center
        • Principal Investigator:
          • Rayne Rouce
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital .
        • Contact:
        • Principal Investigator:
          • Amanda Lipsitt
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Clinical Trials Office .
        • Contact:
        • Principal Investigator:
          • Luke Maese
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Children's Hospital of Richmond at VCU Pediatric Hematology Oncology
        • Contact:
        • Principal Investigator:
          • Elizabeth Krieger
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address
        • Contact:
        • Principal Investigator:
          • Christian Capitini
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Childrens Hospital of Wisconsin
        • Principal Investigator:
          • Julie-An Talano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. CD19 expressing B-cell Acute Lymphoblastic Leukemia
  2. 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.
  3. Age 1 to 25 years at the time of screening
  4. Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%

  5. 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
  6. 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:

  1. M3 marrow at the completion of 1st line induction therapy
  2. 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.
  3. Philadelphia chromosome positive ALL
  4. Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
  5. Prior tyrosine kinase inhibitor therapy
  6. 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.
  7. 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)
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose of CTL019

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
Biological: CTL019

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
Time Frame: 5 years after tisagenlecleucel infusion
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.
5 years after tisagenlecleucel infusion
Overall Survival (OS) rate
Time Frame: 4 years after tisagenlecleucel
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
4 years after tisagenlecleucel

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who are disease free without allogeneic stem cell transplant (SCT)
Time Frame: 12 months after last infusion
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.
12 months after last infusion
Percentage of participants who have tisagenlecleucel product successfully manufactured over the total number of subjects enrolled for the age ≥1 year and < 3 years
Time Frame: 8 years
Success in manufacturing of tisagenlecleucel dose for patients who are ≥1 year and <3 years as respective time points.
8 years
Pediatric Quality of Life (PedsQL)
Time Frame: 5 years

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).
5 years
European Quality of Life 5 dimensions (EQ-5D-3L & EQ-5D-Y))
Time Frame: 5 years

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).
5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Detection test
Time Frame: 5 years
Speed of performance (mean of the log10 transformed reaction times for correct responses)
5 years
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: Identification test
Time Frame: 5 years
This test measures the speed of performance (mean of the log10 transformed reaction times for correct responses)
5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Groton Maze Learning test
Time Frame: 5 years
This test looks at the total number of errors made in attempting to learn the hidden pathways during a single session.
5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: One Back test
Time Frame: 5 years
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).
5 years
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: One card learning test
Time Frame: 5 years
This test measures the accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).
5 years
Percentage of participants with pre-existing antibodies
Time Frame: 8 years
Prevalence of immunogenicity
8 years
Percentage of participants with anti-m CAR19 antibodies post infusion with tisagenlecleucel and % of patients without measureable anti-mCAR19 antibodies
Time Frame: 8 years
Incidence of immunogenicity
8 years
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
Time Frame: 8 years
Impact of immunogenicity on clinical response
8 years
tisagenlecleucel transgene concentration
Time Frame: 8 years
Transgene concentration as detected by qPCR in target tissue
8 years
Expression of tisagenlecleucel
Time Frame: 8 years
Summary of tisagenlecleucel CAR-positive viable T cells measured by flow cytometry in target tissue
8 years
Persistence of CAR (reported as copies/ug) categorized by the time to B-cell recovery (recovery < 3 months, >3 months to < 6months, > 6 months)
Time Frame: 8 years
Relationship between B-cell recovery and transgene levels
8 years
Cmax; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
8 years
Tmax; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
8 years
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The AUC from time zero to day 29 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days )
8 years
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The AUC from time zero to Tmax in peripheral blood (% or copies/μg x days)
8 years
T1/2; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
8 years
Clast; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The last observed quantifiable concentration in peripheral blood (% or copies/μg)
8 years
Tlast; cellular kinetic parameter of tisagenlecleucel
Time Frame: 8 years
The time of last observed quantifiable concentration in peripheral blood (days)
8 years
Impact of tisagenlecleucel dose on day 29 response
Time Frame: 8 years
Clinical response summarized by quartile of administered doses
8 years
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
Time Frame: Day 29
Impact of tisagenlecleucel exposure on day 29 response; The AUC from time zero to day 29 in peripheral blood (% or copies/μg x days )
Day 29
Cmax: cellular kinetic parameter of tisagenlecleucel
Time Frame: Day 29
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)
Day 29
Tmax: cellular kinetic parameter of tisagenlecleucel
Time Frame: Day 29
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)
Day 29
T1/2: cellular kinetic parameter of tisagenlecleucel
Time Frame: Day 29
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
Day 29
DFS rate with censoring for new anticancer therapy, including SCT, while in remission
Time Frame: 5 years
Assessing the effect of tisagenlecleucel on DFS if new anticancer therapy is not available.
5 years
Percentage of participants achieving MRD negative CR or CRi at Month 3
Time Frame: 3 months after the tisagenlecleucel infusion.
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.
3 months after the tisagenlecleucel infusion.
Percentage of participants with in CR or CRi with persistent B-cell aplasia over time post tisagenlecleucel infusion
Time Frame: 8 years
Absolute lymphocyte CD19 count of <50/uL
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Children's Oncology Group

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Estimated)

October 19, 2027

Study Completion (Estimated)

October 19, 2027

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTL019G2201J
  • 2017-002116-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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