CompletedPhase 1

Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy

United States29 participantsStarted 2017-01-31

Plain-language 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).

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓Patients must be ≥ 1 and ≤ 21 years of age at the time of enrollment.
✓. Cohort A: Patients must have less than 320 mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline chemotherapy (See Appendix 2 for anthracycline calculation worksheet).
✓. Cohorts B \& C: There is no limit on prior anthracycline exposure.
✓Patients must have a shortening fraction ≥ 27% or an ejection fraction ≥ 55% by echocardiogram, cardiac MRI or multigated acquisition scan (MUGA).

What they're measuring

Number of Participants With Dose Limiting Toxicities as a Measure of Safety and Tolerability

Timeframe: 9 weeks

Trial details

NCT IDNCT02879643

SponsorTherapeutic Advances in Childhood Leukemia Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-29

Results submitted2025-10-07

View on ClinicalTrials.gov More ALL, Childhood trials