At a glance
ClinicalIndex Comparison Record- ✓Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or lymphoma with L3 morphology, surface IgG expression, or cytogenetic evidence for t(8;14), t(8;22), or t(2;8)
- ✓Previously untreated disease (hydroxyurea for leukocytosis allowed)
- ✓Age 16 years or older
- ✓HIV negative
- ✕Pregnant or nursing
- ✕Concurrent interleukin-11
- ✕Other concurrent chemotherapy
- ✕Concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia
In Brief
A Phase 2 clinical trial evaluating filgrastim, rituximab, and 11 other interventions for Leukemia and Lymphoma. Completed, enrolled 105 participants across 31 sites.
Detailed 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.
Study Details
Timeline
Interventions
5 ug/kg/day sub Q injection day 7 until ANC\>5000/ul courses II-VII
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
200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
1 g/sq m/day IV infusion Days 4 \& 5, courses II, IV, VI
10mg/sq m PO or IV Days 1-5 courses II-VII
25 mg/sq m/day IV infusion Days 4 \& 5 courses III,V, VII
80 mg/sq m/day IV infusion Days 4 \& 5 courses II, IV, VI
800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX \<10nM, courses II-VII
1.5 g/sq m IV infusion Day 1 courses II-VII
60 mg/sq m PO/day Days 1-7 course I
2 mg IV push Day 1 courses II-VII
300 mg/day PO Days 1-14, course I