Status:
COMPLETED
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
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
AIDS-Related Burkitt Lymphoma
Atypical Burkitt/Burkitt-Like Lymphoma
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
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 relapse...
Eligibility Criteria
Inclusion
- Burkitt's or Burkitt-like leukemia/lymphoma, either previously untreated, or relapsed/refractory, or human immunodeficiency virus (HIV)-related; patients with double or triple hit high-grade leukemia/lymphoma are eligible also; patients HIV positive will be described and reported separately or relapsed/refractory acute lymphoblastic leukemia (ALL).
- Zubrod performance status =\< 3 (Eastern Cooperative Oncology Group \[ECOG\] scale)
- 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)
- Adequate cardiac function defined as no history of clinically significant arrhythmia, or history of myocardial infarction (MI) within 3 months prior to study enrollment; cardiac function will be assessed by history and physical examination
Exclusion
- Pregnant or nursing women
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- 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)
Key Trial Info
Start Date :
January 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02199184
Start Date
January 14 2015
End Date
February 17 2023
Last Update
June 11 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030