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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
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute T Cell Leukemia

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
  3. Greater than 5% blasts in the bone marrow
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  1. Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
  2. Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
  3. Isolated extramedullary disease
  4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
  5. Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
  6. 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
  7. Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
  8. Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
  9. 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

    First Posted
    July 16, 2018
    Last Updated
    August 1, 2018
    Sponsor
    Sichuan University
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    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

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

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