Status:
COMPLETED
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
30-120 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the overall response rate, 1-year event-free survival, and overall survival of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00133991
Start Date
July 1 2005
End Date
August 1 2013
Last Update
September 17 2018
Active Locations (2)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
2
Drexel University College of Medicine - Center City Hahnemann Campus
Philadelphia, Pennsylvania, United States, 19102