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

Tracking Information

• First Submitted Date: July 16, 2018
• First Posted Date: August 3, 2018
• Last Update Posted Date: August 3, 2018
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2018)

Establish optimal dose of ruxolitinib [ Time Frame: Upon completion of a 28 day treatment cycle ]

Determine maximum tolerated dose (MTD) of ruxolitinib

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 1, 2018)

• 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.
• Overall response [ Time Frame: At the end of Cycle 2 (each cycle is 60 days) ]
• Complete response [ Time Frame: At the end of Cycle 2 (each cycle is 60 days) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

• Condition: Acute T Cell Leukemia

Intervention

• 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

Study Arms

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).

Interventions:

• Drug: Ruxolitinib
• Drug: Vincristine
• Drug: Prednisone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 1, 2018): 12
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2021
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

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
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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03613428
• Other Study ID Numbers: HX-ETP-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jie Ji, Sichuan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sichuan University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sichuan University
• Verification Date: August 2018