Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00126191
Phase
PHASE2
Status
Terminated

Conditions

  • Atypical Burkitt Lymphoma
  • Burkitt Lymphoma
  • Non-Hodgkins Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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
  • Cyclophosphamide — DRUG
    Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
  • Doxorubicin — DRUG
    Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
  • Vincristine — DRUG
    Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
  • Methotrexate — DRUG
    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
  • Leucovorin — DRUG
    Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
  • Ifosfamide — DRUG
    High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
  • Etoposide — DRUG
    High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
  • Cytarabine — DRUG
    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
  • Mesna — DRUG
    High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle

Study Details

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.

Key Dates

Start date
Jul 31, 2005
Status verified
Apr 2013
Primary completion
Dec 31, 2009
Completion
Jun 30, 2011

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Risk
    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.
  • Experimental: High Risk
    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).

Primary Outcome Measure

Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt [ Time Frame: 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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