Clinical trial · Interventional
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
NCT00669877CI-TRIAL-00032945completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt'S-like Lymphoma | Atypical Burkitt/Burkitt-Like Lymphoma | ALIAS | 0.90 |
| Burkitt's Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyper-CVAD
- description
- Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10\^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10\^9/L by day 21.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dexamethasone
- Drug: G-CSF
- Drug: Cytarabine
- Drug: Methotrexate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. All ages are eligible. 3. Zubrod performance status \< 3 (ECOG Scale, Appendix A). 4. 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). 5. Signed informed consent. Exclusion Criteria: 1\) N/A
References
Publications (0)
Data not yet available
No reference posted for this study.