Status:
COMPLETED
Rituximab, Cyclophosphamide, and G-CSF Followed By Combination Chemotherapy in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant Followed By Rituximab and GM-CSF for Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the patient's bone marrow ...
Detailed Description
OBJECTIVES: * Determine the disease-free and overall survival of patients with refractory diffuse large B-cell lymphoma treated with stem cell mobilization comprising rituximab, cyclophosphamide, and...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following criteria:
- Failed to achieve at least partial remission
- Failed to respond to prior primary therapy or salvage chemotherapy
- Disease progression within 6 weeks after achieving remission
- CD20 expression at diagnosis or relapse
- No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy
- The addition of radiotherapy or a monoclonal antibody to chemotherapy is considered 1 treatment regimen provided the addition was part of the initial treatment plan
- The addition of these therapies due to lack of response or poor response is considered an additional treatment regimen whether given in the front line or salvage setting
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Direct bilirubin ≤ 2 mg/dL
- AST or ALT \< 3 times upper limit of normal
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- Ejection fraction ≥ 40%
- Pulmonary
- DLCO ≥ 60% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No active infection requiring oral or IV antibiotics
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- See Radiotherapy
- Chemotherapy
- See Disease Characteristics
- Radiotherapy
- See Disease Characteristics
- No prior radioimmunotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00242996
Start Date
March 1 2004
End Date
April 1 2007
Last Update
September 28 2017
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410