Phase III Study of OBI-3424 Given by IV to Treat Patients 12 and Older With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma

What this Trial Is About

This trial studies patients with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or T-cell lymphoblastic lymphoma T-LBL. It evaluates the safety, side effects, best dose, and effectiveness of OBI-3424, a chemotherapy drug designed to stop cancer cell growth by killing cells or preventing their division or spread. The study also explores how OBI-3424 affects disease remission and survival outcomes. Patients receive OBI-3424 intravenously over 30 minutes on days 1 and 8 of each 21-day cycle. Treatment can continue for up to 17 cycles if the disease does not progress and side effects remain acceptable. Those who do not show partial remission by the fourth cycle may be removed unless the investigator finds them clinically benefiting. The study includes blood tests, cerebrospinal fluid collection, bone marrow biopsy, and possible CT scans throughout treatment. Participants undergo screening with blood tests and provide samples during treatment. They are monitored regularly with bone marrow samples and imaging to assess disease status and treatment response. Follow-up visits occur monthly for one year, then every two months for another year, every three months for a third year, and every six months for up to five years from registration. Researchers measure the maximum tolerated dose, response rates, side effects, survival, and minimal residual disease among other outcomes.

Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)