Ruxolitinib Plus LVP in Patients With R/R ETP-ALL (NCT03613428) | Clinical Trial Compass
UnknownPhase 1/2
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
12 participantsStarted 2018-12-01
Plain-language 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.
Who can participate
Age range13 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects with early T-precursor ALL, with any of the following:
✓. Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
✓. Greater than 5% blasts in the bone marrow
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion criteria
✕. Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
✕. Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
✕. Isolated extramedullary disease
✕. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
✕. Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
✕. 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
✕. Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
✕
What they're measuring
1
Establish optimal dose of ruxolitinib
Timeframe: Upon completion of a 28 day treatment cycle