NCT00126191

Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk" disease is defined as one area of disease measuring less than 10cm and a normal blood test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria are considered "high risk". * If the patient has "low risk" disease their treatment cycle consist of three cycles of A. * If the patient has "high risk" disease they will receive Cycle A followed by cycle B which will then repeat. * Cycle A consists of the drugs: rituximab, cyclophosphamide, oncovin, doxorubicin and methotrexate (R-CODOX-M). The treatment cycle is approximately 14 days. A spinal tap is performed on day 1 and day 3 of the cycle and the patient will be hospitalized until between day 11 and day 13. After the patient's blood counts return to normal(usually around day 21),the next round of treatment will occur. * Cycle B consists of the drugs: rituximab, ifosfamide, VP-16 and ara-c (IVAC). The treatment cycle is approximately 5 days. A spinal tap is performed on day 4 and once blood counts return to normal the patient will start cycle A again. * After the patient has finished the treatments, they will be re-evaluated with CT scans and PET scans to determine whether or not they are in remission. Every three months for two years, blood tests and CT and PET scans will be performed. Follow up after that will be every 6 months for two years.

Conditions

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

Interventions

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

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-12-01
• Completion: 2011-06-01
• First posted: 2005-08-03
• Last updated: 2013-05-23
• Results posted: 2013-05-23

Locations

2 sites across 1 country: United States