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

• ClinicalTrials.gov Identifier: NCT03613428
• Recruitment Status: Unknown
• First Posted: August 3, 2018
• Last Update Posted: August 3, 2018
• Sponsor: Sichuan University
• Information provided by (Responsible Party): Jie Ji, Sichuan University

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
Acute T Cell Leukemia	Drug: Ruxolitinib; Drug: Vincristine; Drug: Prednisone	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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).
• 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

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 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

Outcome Measures

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) ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
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

Contacts

Contact: Jie Ji, MD; 86-18980605802; jieji@scu.edu.cn

Contact: Ting Liu, MD; 86-28-85422370; liuting@scu.edu.cn

Sponsors and Collaborators

Sichuan University

Investigators

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

More Information

• Responsible Party: Jie Ji, Clinical Professor, Sichuan University
• ClinicalTrials.gov Identifier: NCT03613428
• Other Study ID Numbers: HX-ETP-01
• First Posted: August 3, 2018
• Last Update Posted: August 3, 2018
• Last Verified: August 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; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Prednisone; Vincristine; Anti-Inflammatory Agents; Glucocorticoids; Hormones; 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