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closed due to slow accrual
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Experimental | 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 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Participants are followed after completion of protocol therapy until disease progression to determine disease free survival. | Until disease progression up to 120 months |
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Inclusion Criteria:
Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria.
Pathology must be reviewed at the Brigham and Women's Hospital (BWH).
Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease.
The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease.
Age > 18
Laboratory data (within 2 weeks of study registration):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann S. La Casce, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
Participants with previous chemotherapy or radiation, uncontrolled infection, concomitant malignancy (some exclusions), serious comorbid disease, pregnancy, and HIV+ were excluded. Subjects stratified according to risk: Single focus disease <10cm and normal LGH=low risk, all others high risk.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk | 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). |
| FG001 | High Risk |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cyclophosphamide | Drug | Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A) |
|
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| Doxorubicin | Drug | Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A) |
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| Vincristine | Drug | Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A) |
|
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| 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 |
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| Leucovorin | Drug | Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A) |
|
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| Ifosfamide | Drug | High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle |
|
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| Etoposide | Drug | High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle |
|
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| 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 |
|
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| Mesna | Drug | High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle |
|
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| Boston |
| Massachusetts |
| 02215 |
| United States |
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk | 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). |
| BG001 | High Risk | Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | IRB approved deviation to register 1 patient at age 17. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 3 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival | Participants are followed after completion of protocol therapy until disease progression to determine disease free survival. | One low-risk participant was lost to follow-up after 48 months of disease free survival. | Posted | Mean | Full Range | Months | Until disease progression up to 120 months |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Risk | 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). | 1 | 2 | 0 | 2 | ||
| EG001 | High Risk | Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB). | 2 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilirubin | Metabolism and nutrition disorders | CRCAE 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 3.0 | Systematic Assessment |
| |
| Hyperuricemia | Endocrine disorders | CTCAE 3.0 | Systematic Assessment |
|
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Early termination leading to small numbers of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann LaCasce, MD | DFCI | 617-632-5959 | ALACASCE@PARTNERS.ORG |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| D007069 | Ifosfamide |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D015080 | Mesna |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
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| >=65 years |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|