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A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma

- Achieved a complete or partial response to last salvage therapy

- Completed salvage therapy within the past 12 weeks

- No disease progression since last salvage therapy

- One of the following disease statuses must have been present prior to receiving
salvage therapy

- Refractory to last anti-lymphoma therapy

- Last remission duration less than 1½ years if salvage therapy is 3rd regimen

- Last remission duration less than 3 years if salvage therapy is 2nd regimen

- Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem
cell support

- No leptomeningeal disease or brain parenchyma involvement

PATIENT CHARACTERISTICS:

- Cardiac ejection fraction > 50%

- If over 60 years of age, no evidence of cardiac ischemia by treadmill stress
test (stress echo or sesta-MIBI)

- Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function
testing

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min

- ANC > 1,000/μL

- Platelet count > 50,000/μL

- Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)

- Not pregnant or breast-feeding

- Fertile patients must use an acceptable form of birth control

- HIV I or II negative

- No acute or chronic hepatitis B

- No active hepatitis C

- No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that,
in the opinion of the attending physician and/or principal investigator, would
preclude study treatment

- No other malignancy within the past 5 years except curatively treated cutaneous basal
cell or squamous cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

- No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy

- Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part
of a planned treatment regimen will not be considered distinct regimens

- Chemotherapy administered primarily for the purpose of stem cell mobilization
(e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma
regimen

- No prior autologous or allogeneic hematopoietic stem cell transplantation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 2 years after autologous stem cell transplantation (ASCT)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Craig Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-085

NCT ID:

NCT00521014

Start Date:

October 2007

Completion Date:

October 2013

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021