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

NCT ID: NCT03613428

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

Dose escalation up to 80 mg administered orally

Vincristine

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

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

Interventions

Ruxolitinib

Dose escalation up to 80 mg administered orally

Intervention Type: DRUG

Vincristine

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

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

Other Intervention Names

JAK1/JAK2 inhibitor; Oncovin; steroid

Eligibility Criteria

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

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Jie Ji

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Ji, MD

Role: PRINCIPAL_INVESTIGATOR

West Chinia Hospital, Sichuan University

Central Contacts

Jie Ji, MD

Role: CONTACT

jieji@scu.edu.cn

86-18980605802

Ting Liu, MD

Role: CONTACT

liuting@scu.edu.cn

86-28-85422370

Other Identifiers

HX-ETP-01

Identifier Type: -

Identifier Source: org_study_id