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

NCT03613428 | Unknown Phase 1

• 1 other identifier: HX-ETP-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute T Cell Leukemia

Outcome Measures

Primary Outcomes (1)

• Establish optimal dose of ruxolitinib

  Determine maximum tolerated dose (MTD) of ruxolitinib

  Upon completion of a 28 day treatment cycle

Secondary Outcomes (3)

• Evaluate safety by assessing toxicities

  Upon completion of a 28 day treatment cycle

• Overall response

  At the end of Cycle 2 (each cycle is 60 days)

• Complete response

  At the end of Cycle 2 (each cycle is 60 days)

Study Arms (1)

ruxolitinib, vincristine, prednisone

EXPERIMENTAL

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; Drug: Vincristine; Drug: Prednisone

Interventions

Ruxolitinib DRUG

Dose escalation up to 80 mg administered orally

Also known as: JAK1/JAK2 inhibitor

ruxolitinib, vincristine, prednisone

Vincristine DRUG

1.4 mg/m2 i.v. weekly for 4 weeks

Also known as: Oncovin

ruxolitinib, vincristine, prednisone

Prednisone DRUG

1 mg/kg orally 5 consecutive days per week for 4 weeks.

Also known as: steroid

ruxolitinib, vincristine, prednisone

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

ruxolitinib; Vincristine; Prednisone; Steroids

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jie Ji, MD

  West Chinia Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Ji, MD

CONTACT

86-18980605802; jieji@scu.edu.cn

Ting Liu, MD

CONTACT

86-28-85422370; liuting@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 3, 2018
• Study Start: December 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: March 30, 2021
• Last Updated: August 3, 2018

Record last verified: 2018-08