Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
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|ClinicalTrials.gov Identifier: NCT00133991|
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: Filgrastim Biological: Rituximab Drug: Cyclophosphamide Drug: Cytarabine Drug: Methotrexate Drug: Prednisone Drug: Hydrocortisone Drug: Vincristine Drug: Leucovorin||Phase 2|
- Determine the overall response rate, 1-year event-free survival, and overall survival of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia treated with dose-intensified induction therapy comprising cyclophosphamide, vincristine, prednisone, and rituximab followed by consolidation therapy comprising rituximab and high-dose cyclophosphamide.
- Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability of this regimen in these patients.
- Determine the 3-year event-free survival and overall survival of patients treated with this regimen.
- Determine the general patterns of CNS and systemic relapse in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and rituximab IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV rescue on day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 3 and continuing until blood counts recover. Treatment repeats approximately every 14 days for 2 courses.
- CNS therapy: Patients receive cytarabine intrathecally (IT) with or without hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly during any induction therapy treatment delay. Patients who demonstrate CSF clearance receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses during consolidation therapy. Patients with disease progression during induction therapy or persistent CNS involvement by lymphoma are removed from the study. All other patients proceed to consolidation therapy.
- Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma|
|Actual Study Start Date :||July 2005|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2013|
Experimental: R-CVP + HiCy
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.
375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy.
Other Name: Rituxan
1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.
100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
Other Name: Ara-C
3 g/m^2 on Day 8 of each cycle of R-CVP.
Other Name: MTX
100 mg on Days 1-5 of each cycle of R-CVP.
Other Name: Deltasone
50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.
1.4 mg/m^2 on Day 1 of each cycle of R-CVP.
Other Name: Oncovin
25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.
Other Name: Folinic acid
- Overall Response Rate [ Time Frame: Up to 3 months ]Number of participants who have a complete or partial remission (2007 International Working Group criteria).
- Overall Survival [ Time Frame: 1 year and 3 years ]Percentage of participants alive at 1 year and at 3 years.
- Event-free Survival [ Time Frame: 1 year and 3 years ]Percentage of participants alive without relapse at 1 year and 3 years.
- Percentage of Participants Experiencing Grade 3-5 Toxicity [ Time Frame: Up to 2 years ]Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).
- Relapse Pattern [ Time Frame: Up to 6 months ]Percentage of participants experiencing central nervous system (CNS) and systemic relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133991
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Pennsylvania|
|Drexel University College of Medicine - Center City Hahnemann Campus|
|Philadelphia, Pennsylvania, United States, 19102|
|Study Chair:||Yvette L. Kasamon, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|