Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL
- Conditions
- Lymphoblastic Leukemia, AcuteLymphoblastic Leukemia, Acute, ChildhoodALL, Childhood
- Interventions
- Registration Number
- NCT02879643
- Lead Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Brief Summary
This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
- Detailed Description
This study will utilize Marqibo® as a replacement for standard vincristine in combination with chemotherapy for children with relapsed ALL. The hypothesis is that the incorporation of Marqibo® with combination chemotherapy will be safe and feasible. In the context of this pilot study, overall outcomes and efficacy will be a secondary objective. It is hypothesized that data from this combination may show improved efficacy including, complete remission (CR), minimal residual disease (MRD) negativity, and progression free survival (PFS) rates and safety (i.e., neurotoxicity) in comparison to outcomes in historical regimens, including the UK ALL R3 with standard vincristine.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Marqibo and UK ALL R3 backbone Marqibo * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Cohort C: Marqibo and maintenance regimen Marqibo * Marqibo®: given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Cohort B: Marqibo and lower intensity UK ALL R3 backbone Marqibo * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability 5 weeks The incidence of dose limiting toxicity (DLT) will be measured at different dose levels.
- Secondary Outcome Measures
Name Time Method The response rate after treatment. Approx. 8 weeks The rate of remission will be assessed after 1 courses of therapy. A bone marrow aspirate/biopsy and CBC will be conducted to assess response.
Trial Locations
- Locations (35)
Sidney Kimmel Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Healthcare of Atlanta at Egleston
🇺🇸Atlanta, Georgia, United States
Children's Hospital Orange County
🇺🇸Orange, California, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Children's Hospital New York-Presbyterian
🇺🇸New York, New York, United States
Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
UCSF School of Medicine
🇺🇸San Francisco, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Sainte-Justine University Hospital Center
🇨🇦Montréal, Québec, Canada
The Children's Hospital, University of Colorado
🇺🇸Aurora, Colorado, United States
National Cancer Institute, Pediatric Oncology Branch
🇺🇸Bethesda, Maryland, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
CS Mott Children's Hospital, Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Texas Children's Cancer Center, Baylor
🇺🇸Houston, Texas, United States
Lady Cilento Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital, Melbourne
🇦🇺Parkville,, Victoria, Australia