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
NCT ID: NCT02199184
Last Updated: 2024-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2015-01-14
2023-02-17
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (DA-EPOCH and ofatumumab or rituximab)
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride 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 PO 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.
Cyclophosphamide
Given IV
Doxorubicin Hydrochloride
Given IV
Etoposide
Given IV
Ofatumumab
Given IV
Prednisone
Given PO
Rituximab
Given IV
Vincristine Sulfate
Given IV
Interventions
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Cyclophosphamide
Given IV
Doxorubicin Hydrochloride
Given IV
Etoposide
Given IV
Ofatumumab
Given IV
Prednisone
Given PO
Rituximab
Given IV
Vincristine Sulfate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elias Jabbour, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2014-01707
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0123
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0123
Identifier Type: -
Identifier Source: org_study_id
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