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

NCT02723994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ruxolitinib

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.

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Albert Assad, MD · Incyte Corporation

  • Sarah Tasian, MD · Children's Hospital of Philadelphia, Philadelphia, PA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2026-03-03
Completion
2026-03-03

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02723994 on ClinicalTrials.gov