GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop
      the growth of cancer cells by stopping them from dividing or by killing them. An autologous
      stem cell transplant may be able to replace the blood-forming cells that were destroyed by
      chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or
      peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may
      find any remaining cancer cells and either kill them or deliver cancer-killing substances to
      them without harming normal cells. Giving GM-CSF together with rituximab after autologous
      stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.

      PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after
      autologous stem cell transplant works in treating patients with relapsed or primary
      refractory follicular non-Hodgkin lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the progression-free survival rate at 2 years after autologous stem cell
           transplantation (ASCT) in patients with relapsed or primary refractory follicular
           lymphoma treated with sargramostim (GM-CSF) and rituximab after ASCT.

      Secondary

        -  To assess the safety of administering GM-CSF and rituximab after ASCT.

        -  To assess the effects of GM-CSF on the relative expression of activating and inhibitory
           FcγR on circulating monocytes.

        -  To assess the effects of GM-CSF on the relative expression of activating and inhibitory
           FcγR on circulating dendritic cells.

        -  To assess the effects of GM-CSF on the level of circulating FcγR.

        -  To assess the reconstitution of NK cells, NK-T cells, dendritic cell subsets, and
           regulatory T-cells after ASCT.

      OUTLINE:

        -  High-dose chemotherapy: Patients receive carmustine IV over 2 hours on day -7, etoposide
           IV over 1 hour and cytarabine IV every 12 hours on days -6 to -3, and melphalan IV on
           day -2.

        -  Autologous stem cell transplantation (ASCT): Patients undergo ASCT on day 0. Patients
           receive filgrastim (G-CSF) subcutaneously (SC) once a day beginning on day 5 and
           continuing until blood counts recover.

        -  Sargramostim (GM-CSF) and rituximab: Beginning approximately 7-10 weeks (49-70 days)
           after ASCT, patients receive GM-CSF SC 3 times a week for 8 weeks and rituximab IV once
           weekly for 4 weeks (beginning within 3 days after the first dose of GM-CSF). Patients
           receive a second course of GM-CSF and rituximab (as above) beginning approximately 22-26
           weeks (154-182 days) after ASCT.

      After the completion of study treatment, patients are followed periodically for 2 years.
    

Intervention name(s): filgrastim; rituximab; sargramostim; carmustine; cytarabine; etoposide; melphalan; autologous hematopoietic stem cell transplantation
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cytarabine; Rituximab; Etoposide; Melphalan; Carmustine; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma