Study of Combination Chemotherapy Using Clofarabine, Etoposide, Cyclophosphamide, Liposomal Vincristine, Dexamethasone, and Bortezomib for Patients 15 and Older with Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

What this Trial Is About

This trial studies patients aged 15 years and older with relapsed or refractory acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphomaleukemia, or double-hit lymphomaleukemia. It evaluates the side effects and initial effectiveness of a combination chemotherapy regimen in treating these blood cancers that have returned or do not respond to prior treatment. The study aims to collect safety and response data as well as measure outcomes like survival and event-free survival. Participants receive a combination of chemotherapy drugs including clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib, plus additional drugs like ofatumumab or rituximab. The treatment starts with an induction phase where drugs are given intravenously, subcutaneously, or orally on specific days over one to two weeks. Those who respond may continue with consolidation therapy involving repeated 28-day cycles of similar drugs for up to five courses, depending on disease status and tolerance. Throughout the study, participants undergo regular monitoring for side effects and treatment response. Assessments include measuring adverse events, overall response rates, survival, and event-free survival over up to 8 years. Treatment effects are evaluated through clinical and laboratory tests. The study track participants closely during and after treatment to gather long-term safety and effectiveness information.

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia