A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Conditions

• Leukemia

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  In Part 1, ruxolitinib will be administered at a protocol-defined starting dose in combination with chemotherapy, with dose escalation and de-escalation following the rolling 6 study design. The established recommended starting dose will be taken forward into Part 2.
• Asparaginase Erwinia Chrysanthemi — DRUG
• Cyclophosphamide — DRUG
• Cytarabine — DRUG
• Dexamethasone — DRUG
• Doxorubicin — DRUG
• Leucovorin Calcium — DRUG
• Mercaptopurine — DRUG
• Methotrexate — DRUG
• Pegaspargase — DRUG
• Prednisone — DRUG
• Thioguanine — DRUG
• Vincristine Sulfate — DRUG

Study Details

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

Key Dates

Start date

Sep 30, 2016

Status verified

Mar 2026

Primary completion

Mar 3, 2026

Completion

Mar 3, 2026

Study Design

Enrollment

171 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib in combination with chemotherapy

Primary Outcome Measure

Part 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms [ Time Frame: Part 1: AEs assessed from screening through up to 30 days after the last dose of study drug, expected to be 26 months (females) or 38 months (males) ]

Locations (103)

Find similar trials in Birmingham, AL

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