Phase 2
Completed N=56
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
Source: ClinicalTrials.gov NCT00669877 ↗Enrolled (actual)
56
Serious AEs
48.2%
Results posted
May 2018
Primary outcomePrimary: Complete Remission Rate: Percentage of Participants With Complete Remission (CR) — 85 percentage of participants
Summary
The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. The safety of the combined treatment will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate: Percentage of Participants With Complete Remission (CR) |
85 | — |
Eligibility Criteria
Inclusion Criteria
- Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated, previously treated (may be in CR or with active disease after 1-2 courses of chemotherapy), or HIV-related.
- All ages are eligible.
- Zubrod performance status < 3 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).
- Signed informed consent.
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT00669877). 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. Informational only — not medical advice.