Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Burkitt Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Lymphoma, B-Cell

Lymphosarcoma

B-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Micronutrients

Dermatologic Agents

Reproductive Control Agents

Hematinics

Vitamins

Etoposide

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Leucovorin

Levoleucovorin

Methotrexate

Rituximab

Vincristine

Ifosfamide

Folic Acid

Etoposide phosphate

Isophosphamide mustard

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Antidotes

Protective Agents

Trace Elements

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

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.

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).

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

Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)

Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)

Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)

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

Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)

High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle

High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle

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

High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle

Ann S. La Casce, MD

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.

* 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.

Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

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 are followed after completion of protocol therapy until disease progression to determine disease free survival.

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Assistant Professor of Medicine

Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.

Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).

Low Risk

Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).

High Risk

Total

IRB approved deviation to register 1 patient at age 17.

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small numbers of subjects analyzed.

Ann LaCasce, MD

Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt

One low-risk participant was lost to follow-up after 48 months of disease free survival.

Spots Global Cancer Trial Database for atypical burkitt lymphoma