NCT00039130

Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.

Detailed description

OBJECTIVES: * Determine the complete response rate in patients with previously untreated Burkitt's lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy with filgrastim (G-CSF) support. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the feasibility and toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma). * Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14. * Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4 and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2, patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4 and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood counts recover. * Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5; oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and 6. After course 3, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 ug/kg/day sub Q injection day 7 until ANC\>5000/ul courses II-VII
BIOLOGICAL	rituximab	Day 8 course II 50 mg/sq m IV infusion: d 8 course IV \& VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
DRUG	cyclophosphamide	200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
DRUG	cytarabine	1 g/sq m/day IV infusion Days 4 \& 5, courses II, IV, VI
DRUG	dexamethasone	10mg/sq m PO or IV Days 1-5 courses II-VII
DRUG	doxorubicin hydrochloride	25 mg/sq m/day IV infusion Days 4 \& 5 courses III,V, VII
DRUG	etoposide	80 mg/sq m/day IV infusion Days 4 \& 5 courses II, IV, VI
DRUG	ifosfamide	800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
DRUG	leucovorin calcium	25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX \<10nM, courses II-VII
DRUG	methotrexate	1.5 g/sq m IV infusion Day 1 courses II-VII
DRUG	prednisone	60 mg/sq m PO/day Days 1-7 course I
DRUG	vincristine sulfate	2 mg IV push Day 1 courses II-VII
DRUG	Allopurinol	300 mg/day PO Days 1-14, course I

Timeline

• Start date: 2002-05-01
• Primary completion: 2010-09-01
• Completion: 2014-10-01
• First posted: 2003-01-27
• Last updated: 2023-08-21
• Results posted: 2014-10-22

Locations

31 sites across 1 country: United States