NCT02723994|CompletedPhase 2DMC

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

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

Incyte Corporation ClinicalTrials.gov

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2 other identifiers

INCB 18424-269AALL1521

Study Type

interventional

Target

171

Locations

3 countries

Sites

111

Timeline

RegisteredMar 2016

StartedSep 2016

CompletionMar 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

171

participants targeted

Target at P75+ for phase_2 leukemia

Timeline

Completed

Started Sep 2016

Longer than P75 for phase_2 leukemia

Geographic Reach

3 countries

111 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.4 years study duration

First Submitted

Initial submission to the registry

March 9, 2016

Completed

22 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed

6 months until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed

9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

9.4 years

First QC Date

March 9, 2016

Last Update Submit

March 9, 2026

Conditions

Leukemia

Keywords

B-cell acute lymphoblastic leukemia (ALL)pediatricmulti-agent chemotherapyJAK inhibitor

Outcome Measures

Primary Outcomes (2)

Part 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms
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)
Part 2: Efficacy of ruxolitinib in combination with chemotherapy as measured by Event-free survival, defined as the percentage of patients alive without relapse, progression, or death at 3 years from study Day 1
Part 2: assessed at 3 years

Secondary Outcomes (1)

Safety and tolerability of the combination treatment for subjects beginning treatment at the recommended dose for Part 2, as assessed by AEs, vital signs, clinical laboratory tests, and echocardiograms
AEs assessed from screening through up to 30 days after the last dose of study treatment, expected to be 26 months (females) or 38 months (males)

Study Arms (1)

Ruxolitinib in combination with chemotherapy

EXPERIMENTAL

Drug: RuxolitinibDrug: Asparaginase Erwinia ChrysanthemiDrug: CyclophosphamideDrug: CytarabineDrug: DexamethasoneDrug: DoxorubicinDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneDrug: ThioguanineDrug: Vincristine Sulfate