Status:
UNKNOWN
GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Lead Sponsor:
French Innovative Leukemia Organisation
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth...
Detailed Description
OBJECTIVES: Primary * Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
- Grade 1-3a disease
- Stage II-IV disease
- Non-bulky disease
- Must have undergone initial nodal biopsy within the past 4 months
- At least 1 measurable lesion
- Low tumor-burden, as defined by the following GELF criteria:
- Nodal or extranodal tumor mass (diameter \< 7 cm)
- No systemic B symptoms
- No increased LDH and β2 microglobulinemia
- No substantial splenic enlargement
- No serous effusion
- No compression syndrome
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active hepatitis
- PRIOR CONCURRENT THERAPY:
- No prior treatment, including steroids and radiotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00893477
Start Date
March 1 2009
Last Update
August 2 2013
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