Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Ann S. La Casce, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|