GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00896519
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
  • sargramostim — BIOLOGICAL
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG
  • gene expression analysis — GENETIC
  • gene rearrangement analysis — GENETIC
  • polymerase chain reaction — GENETIC
  • R-CHOP regimen — OTHER
  • laboratory biomarker analysis — OTHER

Study Details

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and combination chemotherapy works in treating patients with previously untreated advanced follicular non-Hodgkin lymphoma.

Key Dates

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

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Overall objective tumor response rate

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