Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
- Conditions
- Acute T Cell Leukemia
- Interventions
- Registration Number
- NCT03613428
- Lead Sponsor
- Sichuan University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
-
Subjects with early T-precursor ALL, with any of the following:
- refractory to primary induction therapy or refractory to salvage therapy,
- in untreated first relapse with first remission duration <12 months
- in untreated second or greater relapse
- relapse at any time after allogeneic HSCT
-
Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
-
Greater than 5% blasts in the bone marrow
-
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
- Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
- Isolated extramedullary disease
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
- Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
- Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
- Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
- Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ruxolitinib, vincristine, prednisone 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). ruxolitinib, vincristine, prednisone Ruxolitinib 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). ruxolitinib, vincristine, prednisone Vincristine 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 Measures
Name Time Method Establish optimal dose of ruxolitinib Upon completion of a 28 day treatment cycle Determine maximum tolerated dose (MTD) of ruxolitinib
- Secondary Outcome Measures
Name Time Method Overall response At the end of Cycle 2 (each cycle is 60 days) Evaluate safety by assessing toxicities Upon completion of a 28 day treatment cycle Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.
Complete response At the end of Cycle 2 (each cycle is 60 days)