M9177: Phase II Study of Dose-Adjusted EPOCH+/- Rituximab in Adults with Untreated Burkitt Lymphoma, C-Myc Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma
- Zale Lipshy University Hospital
Prapti Patel, M.D.
This is a phase ii Study of risk adapted Da-ePoCH-R in BL, c-MYC + DLBCL and Da-ePoCH in c-MYC+ plasmablastic lymphoma.
The Da-ePoCH-R regimen represents a major paradigm shift for the treatment of BL. Whereas standard treatment relies on dose density and intensity based on methotrexate and cytarabine to achieve adequate cell kill, Da-ePoCH-R relies on a pharmacodynamic based infusional schedule to improve the therapeutic index of chemotherapy. Based on our pilot results, Da[?] ePoCH-R appears to provide a high rate of cure with significantly lower treatment toxicity and tumor lysis syndrome compared to standard treatment. as such, Da-ePoCH-R may provide a major treatment advance in BL by lowering morbidity, mortality and cost, while maintaining or possibly improving efficacy. The current protocol is written to confirm our pilot results of Da[?] ePoCH-R in BL and in particular to obtain further results in patients with advanced stage disease. We also plan to obtain pilot information on potential differences in the microarray of BL in HiV positive and negative patients.
1. Burkitt lymphoma or B-cell lymphoma, unclassifiable, with features intermediate between Diffuse Large B-cell lymphoma** and Burkitt Lymphoma, c-MYC + DLBCL or c-MYC+ plasmablastic lymphoma by histology. For c-MYC + cases, a MYC rearrangement must be documented before study enrollment. If questions arise related to diagnosis, please contact the NCI PI, Dr. Dunleavy or the NCI study coordinator, A. Nicole Lucas
2. Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of EPOCH-R in patients < 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
3. Pathology confirmed by treating institution's Pathology Department.
4. No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome).
5. All disease stages.
6. HIV negative or positive.
7. HIV positive patients on antiretrovival therapy regimen must be willing to suspend all Highly Active Antiretroviral Therapy (HAART) except in circumstances described in section 6.5 of the protocol.
8. ECOG 0-4
9. Ability of patient or durable power of attorney (DPA) for healthcare to give informed consent.
**In the interest of completing the CALGB 50303 study, Alliance members should consider enrolling patients with a diagnosis of DLBCL onto the CALGB 50303 study.