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GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

filgrastim

rituximab

sargramostim

carmustine

cytarabine

etoposide

melphalan

autologous hematopoietic stem cell transplantation

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-CSF and Rituximab After Autologous Stem Cell Transplant

Arm Description

GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, administered on alternate days. Thus, 24 doses of GM-CSF will be administered. Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF; rituximab. The second course of GM-CSF and rituximab will be administered approximately 22-26 weeks (day +154 to +182) after ASCT.

Outcomes

Primary Outcome Measures

Progression-free Survival Rate

after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as: ≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR appearance of any new lesions

Secondary Outcome Measures

Full Information

NCT ID

NCT00521014

First Posted

August 24, 2007

Last Updated

November 18, 2015

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00521014

Brief Title

GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GM-CSF and Rituximab After Autologous Stem Cell Transplant

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Type

Biological

Intervention Name(s)

sargramostim

Intervention Type

Drug

Intervention Name(s)

carmustine

Intervention Type

Drug

Intervention Name(s)

cytarabine

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

melphalan

Intervention Type

Procedure

Intervention Name(s)

autologous hematopoietic stem cell transplantation

Primary Outcome Measure Information:

Title

Progression-free Survival Rate

Description

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Moskowitz, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew Matasar, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

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GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

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