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Vinca alkaloids
Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL
Phase 1
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 8 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial is testing a new combination of drugs to treat relapsed acute lymphoblastic leukemia.
Eligible Conditions
- Leukemia
- Childhood Leukemia
- Acute Lymphoblastic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx. 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability
Secondary study objectives
Therapeutic procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: Marqibo and maintenance regimenExperimental Treatment1 Intervention
* 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
Group II: Cohort B: Marqibo and lower intensity UK ALL R3 backboneExperimental Treatment1 Intervention
* 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.
Group III: Cohort A: Marqibo and UK ALL R3 backboneExperimental Treatment1 Intervention
* 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Find a Location
Who is running the clinical trial?
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,139 Total Patients Enrolled
Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
641 Total Patients Enrolled