Phase 2
N=105
Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00039130 ↗Enrolled (actual)
105
Serious AEs
58.1%
Results posted
Oct 2014
Primary outcome: Primary: Complete Response Rate — 83 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); rituximab (Biological); cyclophosphamide (Drug); cytarabine (Drug); dexamethasone (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); ifosfamide (Drug); leucovorin calcium (Drug); methotrexate (Drug); prednisone (Drug); vincristine sulfate (Drug); Allopurinol (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate |
83 | — |
| SECONDARY 2 Year Event Free Survival |
78 | — |
| SECONDARY 2 Year Overall Survival |
80 | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or Burkitt's or Burkitt-like lymphoma
- L3 morphology surface IgG expression
- Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)
- Previously untreated disease except hydroxyurea for leukocytosis
- CNS involvement allowed
- Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement must also be enrolled on CALGB-8461
- Patients with Burkitt's leukemia must also be enrolled on CALGB-9665
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent interleukin-11
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes)
- No concurrent steroids except for adrenal failure
Radiotherapy:
- No concurrent palliative radiotherapy except whole-brain irradiation for documented CNS disease
Data sourced from ClinicalTrials.gov (NCT00039130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.