Clinical trial · Interventional
Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma
NCT00126191CI-TRIAL-00010394terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): closed due to slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Burkitt Lymphoma | — | UNRESOLVED | — |
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low Risk
- description
- Low-risk patients receive 3 cycles of regimen A. Regimen A: Rituximab (375 mg/m\^2) on Days 1 and 3. Cyclophosphamide (800 mg/m\^2) on days 1 and 2. Vincristine (1.4 mg/m\^2) on days 1 and 10. Doxorubicin (50 mg/m\^2) on Day 1. Methotrexate (3000 mg/m\^2) on Day 10. Intrathecal Cytarabine (50mg) will be given on Day 1 and intrathecal methotrexate (12mg) will be given on Days 1 and 10. Leucovorin on days 11 and 12. Rituximab is given on Days 1 and 3 in cycle 1, and on Day 1 of all other cycles.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Methotrexate
- Drug: Leucovorin
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- High Risk
- description
- High-risk patients receive 4 alternating cycles of regimens A and B (A-B-A-B). Regimen A (as described earlier). Regimen B: Rituximab (375mg/m\^2) on Day 1. Ifosfamide (1500mg/m\^2) on Days 1-5. Mesna (275 mg/m\^2) on Days 1-5. Etoposide (60mg/mg\^2) on Days 1-5. Cytarabine (2 gm/m\^2) twice a day on Days 1 and 2. Intrathecal methotrexate (12mg) on Day 5, and intrathecal methotrexate (50mg) on Day 3 (also on Day 1 for patients with central nervous system involvement).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria. * Pathology must be reviewed at the Brigham and Women's Hospital (BWH). * Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease. * The following may not be used as the sole site of measurable or evaluable disease: \*ascites, \*pleural effusion, \*bone lesion or \*central nervous system (CNS) disease. * Age \> 18 * Laboratory data (within 2 weeks of study registration): * ANC \> 1500/ul; * platelet \> 100,000/ul; * creatinine \< 1.5 X normal; * creatinine clearance \> 60 ml/min; * bilirubin \< 1.5 X normal; * AST and ALT \< 2.5 X normal; * alkaline phosphates \< 3 X normal; * HIV negative; * cardiac ejection fraction \> 50%. Exclusion Criteria: * Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed. * Uncontrolled bacterial, fungal, or viral infection. * Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin. * Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of \> 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of \> 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be \> 50%. * Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study. * Major surgery within the previous 2 weeks.
References
Publications (0)
Data not yet available
No reference posted for this study.