Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
M.D. Anderson Cancer Center
Summary
This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Description
PRIMARY OBJECTIVE: I. To collect the safety/toxicity information and assess the initial efficacy information (objective overall response rate: complete response \[CR\]+ CR with incomplete platelet recovery \[CRp\]/CR with incomplete bone marrow recovery \[CRi\]) after treatment with clofarabine, etoposide, cyclophosphamide (CEC), vincristine sulfate liposome (liposomal vincristine) (VCR), dexamethasone and bortezomib in relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) including relapsed/refractory Philadelphia (Ph) positive B-ALL/LL or Burkitt's leukemia/l…
Eligibility
- Age range
- 15+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): * Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II) * Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only) * At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual…
Interventions
- DrugBortezomib
Given SC
- DrugClofarabine
Given IV
- DrugCyclophosphamide
Given IV
- DrugDexamethasone
Given IV or PO
- DrugEtoposide
Given IV
- BiologicalOfatumumab
Given IV
- BiologicalPegfilgrastim
Given SC
- Biological
Location
- M D Anderson Cancer CenterHouston, Texas