Phase 2
N=21
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00133991 ↗Enrolled (actual)
21
Serious AEs
57.1%
Results posted
Sep 2018
Primary outcome: Primary: Overall Response Rate — 11; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Filgrastim (Biological); Rituximab (Biological); Cyclophosphamide (Drug); Cytarabine (Drug); Methotrexate (Drug); Prednisone (Drug); Hydrocortisone (Drug); Vincristine (Drug); Leucovorin (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
11; 2 | — |
| PRIMARY Overall Survival |
57; 57 | — |
| PRIMARY Event-free Survival |
52; 52 | — |
| PRIMARY Percentage of Participants Experiencing Grade 3-5 Toxicity |
21 | — |
| SECONDARY Relapse Pattern |
3; 2 | — |
Summary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Classic, sporadic Burkitt's lymphoma
- Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)
- Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following criteria:
- Characteristic morphologic features
- High proliferative index AND Ki-67 ≥ 85%
- Any stage allowed
- Newly diagnosed or untreated disease
- Steroids allowed
PATIENT CHARACTERISTICS:
Age
- 30 and over
Performance status
- Not specified
Life expectancy
- Not specified
Renal
- No known irreversible renal dysfunction that would preclude treatment with high-dose cyclophosphamide
Cardiovascular
- No known significant cardiac dysfunction that would preclude treatment with high-dose cyclophosphamide
Other
- Not pregnant or nursing
- No known HIV positivity
- No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for lymphoma
- A maximum of 2 prior doses of intrathecal chemotherapy are allowed
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiation therapy for lymphoma
Surgery
- Prior complete or incomplete surgical resection of lymphoma allowed
Data sourced from ClinicalTrials.gov (NCT00133991). 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.