GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00893477
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • sargramostim — BIOLOGICAL
  • gene expression analysis — GENETIC
  • gene rearrangement analysis — GENETIC
  • polymerase chain reaction — GENETIC
  • polymorphism analysis — GENETIC
  • laboratory biomarker analysis — OTHER

Study Details

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 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 GM-CSF together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

Key Dates

Start date
Mar 31, 2009
Status verified
Jul 2009
Primary completion
Mar 31, 2011

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Overall objective tumor response rate at the end of induction therapy

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