A Phase 2 interventional study of Rituximab and Cyclophosphamide in Burkitt Lymphoma, Non-Hodgkins Lymphoma and Atypical Burkitt Lymphoma, sponsored by Dana-Farber Cancer Institute. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-23.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 10 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory data (within 2 weeks of study registration):
Exclusion Criteria:
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.
Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Methotrexate · Drug: Leucovorin · Drug: Cytarabine
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).
Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Methotrexate · Drug: Leucovorin · Drug: Ifosfamide · Drug: Etoposide · Drug: Cytarabine · Drug: Mesna
Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1
Also known as: Rituxan
Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
Also known as: Cytoxan
Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
Also known as: Adriamycin, Rubex
Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
Also known as: Oncovin, vincristine sulfate
Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle
Also known as: Rheumatrex, Trexall
Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
Also known as: Folinic acid
High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
Also known as: Ifex
High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
Also known as: Vepesid
Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle
Also known as: Cytosar, Tarabine PFS
High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle
Also known as: Mesnex
Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt
Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.
Time frame: 3 years
Disease Free Survival
Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.
Time frame: Until disease progression up to 120 months
This BL protocl was IRB approved 01/18/05, activated 7/18/05. Participants were identified either in the outpatient clinic at DFCI or while admitted to our partner inpatient hospital, Brigham \& Women's Hospital. The study was closed to accrual 6/2/08 due to slow accrual.
| Milestone | Low Risk | High Risk |
|---|---|---|
| Started | 2 | 8 |
| Completed | 2 | 6 |
| Not completed | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Death | 0 | 1 |
Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.
| participants | Low Risk | High Risk |
|---|---|---|
| Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt | 2 | 7 |
Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.
| Months | Low Risk | High Risk |
|---|---|---|
| Disease Free Survival | 84 (84 to 84) | 52 (2 to 83) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Risk | — | 1/2 (50%) | 0/2 (0%) |
| High Risk | — | 2/8 (25%) | 0/8 (0%) |
| Event | Low Risk | High Risk |
|---|---|---|
| BilirubinMetabolism and nutrition disorders | 1/2 | 1/8 |
| FatigueGeneral disorders | 1/2 | 1/8 |
| HyperuricemiaEndocrine disorders | 1/2 | 1/8 |
| Age, Categorical(Participants) | Low Risk | High Risk | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 1 | 8 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Categorical(Participants) | Low Risk | High Risk | Total |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 1 | 8 | 9 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Low Risk | High Risk | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 2 | 7 | 9 |
| Region of Enrollment(participants) | Low Risk | High Risk | Total |
|---|---|---|---|
| United States | 2 | 8 | 10 |
This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute