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

Sponsor
Sichuan University
Study ID
NCT03613428
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Acute T Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
13 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Dose escalation up to 80 mg administered orally
  • Vincristine — DRUG
    1.4 mg/m2 i.v. weekly for 4 weeks
  • Prednisone — DRUG
    1 mg/kg orally 5 consecutive days per week for 4 weeks.

Study Details

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.

Key Dates

Start date
Dec 1, 2018
Status verified
Aug 2018
Primary completion
Dec 30, 2020
Completion
Mar 30, 2021

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ruxolitinib, vincristine, prednisone
    Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).

Primary Outcome Measure

Establish optimal dose of ruxolitinib [ Time Frame: Upon completion of a 28 day treatment cycle ]

Central Contacts