Clinical trial NCT03613428: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute T Cell Leukemia
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Establish optimal dose of ruxolitinib
timeFrame: Upon completion of a 28 day treatment cycle
Secondary outcomes:
measure: Evaluate safety by assessing toxicities
timeFrame: Upon completion of a 28 day treatment cycle
measure: Overall response
timeFrame: At the end of Cycle 2 (each cycle is 60 days)
measure: Complete response
timeFrame: At the end of Cycle 2 (each cycle is 60 days)
Other outcomes:
Locations:
Study officials:
affiliation: West Chinia Hospital, Sichuan University
name: Jie Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: