Phase 2
N=14
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
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
Bottom Line
View on ClinicalTrials.gov: NCT02199184 ↗Enrolled (actual)
14
Serious AEs
28.6%
Results posted
Jun 2024
Primary outcome: Primary: Participants With a Response — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Doxorubicin Hydrochloride (Drug); Etoposide (Drug); Ofatumumab (Biological); Prednisone (Drug); Rituximab (Biological); Vincristine Sulfate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Response |
9 | — |
| SECONDARY Overall Survival Time |
15.1 | — |
| SECONDARY Event-free Survival |
3.3 | — |
| SECONDARY Complete Response Duration |
10.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02199184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.