Ruxolitinib Plus LVP in Patients With R/R ETP-ALL

NCT03613428 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-03

No results posted yet for this study

Summary

To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.

Conditions

  • Acute T Cell Leukemia

Interventions

DRUG

Ruxolitinib

Dose escalation up to 80 mg administered orally

DRUG

Vincristine

1.4 mg/m2 i.v. weekly for 4 weeks

DRUG

Prednisone

1 mg/kg orally 5 consecutive days per week for 4 weeks.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Jie Ji, MD · West Chinia Hospital, Sichuan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-30
Completion
2021-03-30

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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 NCT03613428 on ClinicalTrials.gov