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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    40
  • sponsor
    M.D. Anderson Cancer Center
Updated on 24 January 2021
cancer
lymphoid leukemia
cyclophosphamide
immunodeficiency
lymphoma
rituximab
vincristine
monoclonal antibodies
prednisone
arrhythmia
leukemia
etoposide
burkitt's lymphoma
monoclonal antibody therapy
monoclonal protein

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.

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.

Details
Condition leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, Refractory Adult Acute Lymphoblastic Leukemia, Recurrent Burkitt Lymphoma, Refractory Burkitt Lymphoma, Refractory Childhood Acute Lymphoblastic Leukemia, Leukemia (Pediatric), Recurrent Childhood Burkitt Lymphoma, Recurrent Acute Lymphoblastic Leukemia, 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, 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, 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, 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
Treatment Rituximab, G-CSF, cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisone, vincristine sulfate, vincristine, doxorubicin, pegfilgrastim, Ofatumumab, Phone Calls
Clinical Study IdentifierNCT02199184
SponsorM.D. Anderson Cancer Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Refractory Childhood Acute Lymphoblastic Leukemia or High-Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements or AIDS-Related Burkitt Lympho...?
Do you have any of these conditions: High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements or Atypical Burkitt/Burkitt-Like Lymphoma or Recurrent Childhood Acute Lymphoblast...?
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 Criteria

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)
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