Phase 2
N=56
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
Burkitt's Lymphoma · Burkitt'S-like Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00669877 ↗Enrolled (actual)
56
Serious AEs
48.2%
Results posted
May 2018
Primary outcome: Primary: Complete Remission Rate: Percentage of Participants With Complete Remission (CR) — 85 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Dexamethasone (Drug); G-CSF (Drug); Cytarabine (Drug); Methotrexate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate: Percentage of Participants With Complete Remission (CR) |
85 | — |
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.
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.