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
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if adding ofatumumab/rituximab to the standard combination of DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine, and cyclophosphamide) can help control the disease in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or relapsed/refractory ALL. The safety of this drug combination will also be studied.
Disease Group: Leukemia
Treatment Agent: Cyclophosphamide,Cytarabine,Doxorubicin,Etoposide,G-CSF,Methotrexate,MESNA,Prednisone,Vincristine
Treatment Location: Only at MDACC
Primary Objective: To evaluate the clinical efficacy of the combination of DA-EPOCH + ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or relapsed/refractory acutle lymphoblastic leukemia (ALL) defined by complete response rate. Secondary Objective: To evaluate the safety of this combination, the overall survival and event-free survival rates.
IRB Review and Approval Date: 01/14/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Burkitt’s or Burkitt-like leukemia/lymphoma, either previously
untreated, or relapsed/refractory, or HIV-related. Patients HIV positive
will be described and reported separately or relapsed/refractory acute
lymphoblastic leukemia (ALL).
2) All ages are eligible
3) Zubrod performance status </= 3 (ECOG Scale, Appendix E)
4) Adequate organ function with creatinine less than or equal to 2.0 mg/dL (unless considered tumor related), bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related).
5) Adequate cardiac function defined as no history of clinically significant arrhythmia, or history of MI within 3 months prior to study enrollment. Cardiac function will be assessed by history and physical examination.
1) Pregnant or nursing women.
2) Active and uncontrolled disease/infection as judged by the treating physician
3) Unable or unwilling to sign the consent form
4) Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
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