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

Acute T Cell Leukemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03613428
• Other study ID #: HX-ETP-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2018
• Source: Sichuan University
• Contact: Jie Ji, MD
• Phone: 86-18980605802
• Email: jieji[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute T Cell Leukemia
• Leukemia
• Leukemia, T-Cell
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Ruxolitinib
Dose escalation up to 80 mg administered orally
• Vincristine
1.4 mg/m2 i.v. weekly for 4 weeks
• Prednisone
1 mg/kg orally 5 consecutive days per week for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish optimal dose of ruxolitinib	Determine maximum tolerated dose (MTD) of ruxolitinib	Upon completion of a 28 day treatment cycle
Secondary	Evaluate safety by assessing toxicities	Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.	Upon completion of a 28 day treatment cycle
Secondary	Overall response		At the end of Cycle 2 (each cycle is 60 days)
Secondary	Complete response		At the end of Cycle 2 (each cycle is 60 days)