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

Sponsor
Sichuan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03613428
Collaborator
(none)
12
Enrollment
1
Arm
27.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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).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)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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).

Drug: Ruxolitinib
Dose escalation up to 80 mg administered orally
Other Names:
  • JAK1/JAK2 inhibitor

    • Drug: Vincristine
    1.4 mg/m2 i.v. weekly for 4 weeks
    Other Names:
  • Oncovin

    • Drug: Prednisone
    1 mg/kg orally 5 consecutive days per week for 4 weeks.
    Other Names:
  • steroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Establish optimal dose of ruxolitinib [Upon completion of a 28 day treatment cycle]

      Determine maximum tolerated dose (MTD) of ruxolitinib

    Secondary Outcome Measures

    1. 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.

    2. Overall response [At the end of Cycle 2 (each cycle is 60 days)]

    3. Complete response [At the end of Cycle 2 (each cycle is 60 days)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.

    2. Greater than 5% blasts in the bone marrow

    3. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sichuan University

    Investigators

    • Principal Investigator: Jie Ji, MD, West Chinia Hospital, Sichuan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jie Ji, Clinical Professor, Sichuan University
    ClinicalTrials.gov Identifier:
    NCT03613428
    Other Study ID Numbers:
    • HX-ETP-01
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Aug 3, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, T-Cell
    Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
    Prednisone
    Vincristine

    Study Results

    No Results Posted as of Aug 3, 2018