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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03613428
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Jie Ji, 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.

Condition or disease Intervention/treatment Phase
Acute T Cell Leukemia Drug: Ruxolitinib Drug: Vincristine Drug: Prednisone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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).
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 30, 2021

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 Name: JAK1/JAK2 inhibitor

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

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

Primary Outcome Measures :
  1. Establish optimal dose of ruxolitinib [ Time Frame: Upon completion of a 28 day treatment cycle ]
    Determine maximum tolerated dose (MTD) of ruxolitinib

Secondary Outcome Measures :
  1. Evaluate safety by assessing toxicities [ Time Frame: 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 [ Time Frame: At the end of Cycle 2 (each cycle is 60 days) ]
  3. Complete response [ Time Frame: At the end of Cycle 2 (each cycle is 60 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 75 Years   (Child, Adult, Older Adult)
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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03613428

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Contact: Jie Ji, MD 86-18980605802
Contact: Ting Liu, MD 86-28-85422370

Sponsors and Collaborators
Sichuan University
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Principal Investigator: Jie Ji, MD West Chinia Hospital, Sichuan University

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Responsible Party: Jie Ji, Clinical Professor, Sichuan University Identifier: NCT03613428     History of Changes
Other Study ID Numbers: HX-ETP-01
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, T-Cell
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action