Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
Primary Purpose
Acute T Cell Leukemia
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ruxolitinib
Vincristine
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Acute T Cell Leukemia
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ruxolitinib, vincristine, prednisone
Arm Description
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).
Outcomes
Primary Outcome Measures
Establish optimal dose of ruxolitinib
Determine maximum tolerated dose (MTD) of ruxolitinib
Secondary Outcome Measures
Evaluate safety by assessing toxicities
Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.
Overall response
Complete response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03613428
Brief Title
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
Official Title
Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute T Cell Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label dosing cohorts will evaluate oral ruxolinitib (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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ruxolitinib, vincristine, prednisone
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
JAK1/JAK2 inhibitor
Intervention Description
Dose escalation up to 80 mg administered orally
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
1.4 mg/m2 i.v. weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
steroid
Intervention Description
1 mg/kg orally 5 consecutive days per week for 4 weeks.
Primary Outcome Measure Information:
Title
Establish optimal dose of ruxolitinib
Description
Determine maximum tolerated dose (MTD) of ruxolitinib
Time Frame
Upon completion of a 28 day treatment cycle
Secondary Outcome Measure Information:
Title
Evaluate safety by assessing toxicities
Description
Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.
Time Frame
Upon completion of a 28 day treatment cycle
Title
Overall response
Time Frame
At the end of Cycle 2 (each cycle is 60 days)
Title
Complete response
Time Frame
At the end of Cycle 2 (each cycle is 60 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Ji, MD
Phone
86-18980605802
Email
jieji@scu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Liu, MD
Phone
86-28-85422370
Email
liuting@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Ji, MD
Organizational Affiliation
West Chinia Hospital, Sichuan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
We'll reach out to this number within 24 hrs