NCT02199184

Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well a dose adjusted regimen consisting of etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) works in combination with ofatumumab or rituximab in treating patients with Burkitt lymphoma that is newly diagnosed, or has returned after a period of improvement (relapsed), or has not responded to previous treatment (refractory) or relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) together with monoclonal antibody therapy may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the clinical efficacy of the combination of dose adjusted (DA)-EPOCH + ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or relapsed/refractory acute lymphoblastic leukemia (ALL) defined by complete response rate. SECONDARY OBJECTIVE: I. To evaluate the safety of this combination, the overall survival and event-free survival rates. OUTLINE: Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride intravenously (IV), vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone orally (PO) twice daily (BID) on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-4 months for 1 year and then every 4-8 months for 2 years.

Conditions

• AIDS-Related Burkitt Lymphoma
• Atypical Burkitt/Burkitt-Like Lymphoma
• High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Burkitt Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Burkitt Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
DRUG	Etoposide	Given IV
BIOLOGICAL	Ofatumumab	Given IV
DRUG	Prednisone	Given PO
BIOLOGICAL	Rituximab	Given IV
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2015-01-14
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2014-07-24
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study