Marqibo for Acute Lymphoblastic Leukemia

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 8 weeks for reporting.

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

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