Acute T Cell Leukemia
Conditions
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.
Interventions
DRUGRuxolitinib
Dose escalation up to 80 mg administered orally
DRUGVincristine
1.4 mg/m2 i.v. weekly for 4 weeks
DRUGPrednisone
1 mg/kg orally 5 consecutive days per week for 4 weeks.
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish optimal dose of ruxolitinib | Upon completion of a 28 day treatment cycle | Determine maximum tolerated dose (MTD) of ruxolitinib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response | At the end of Cycle 2 (each cycle is 60 days) | — |
| Complete response | At the end of Cycle 2 (each cycle is 60 days) | — |
| Evaluate safety by assessing toxicities | 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. |
Contacts
Primary ContactJie Ji, MD
Backup ContactTing Liu, MD
Outcome results
None listed