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

Conditions

• Leukemia
• Lymphoma

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 31, 2002

Status verified

Aug 2023

Primary completion

Sep 30, 2010

Completion

Oct 31, 2014

Study Design

Enrollment

105 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab with High Intensity Chemotherapy
  Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6) Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)

Primary Outcome Measure

Complete Response Rate [ Time Frame: 6 months ]

Locations (31)

Find similar trials in San Diego, CA

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