VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00274794

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

74.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: filgrastim Biological: rituximab	N/A

Detailed Description

OBJECTIVES:

Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients.

OUTLINE: This is a randomized study.

Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.
Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3 and -2.
Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once daily until blood counts recover.

After completion study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies

Study Start Date :

Feb 1, 2000

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: Rituxan + Etoposide + G-CSF	Biological: filgrastim 10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide Biological: rituximab 375 mg/m2, IV, Once per week for 3 weeks.
Other: Etoposide + G-CSF	Biological: filgrastim 10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide

Arm

Intervention/Treatment

Other: Rituxan + Etoposide + G-CSF

Biological: filgrastim

10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide

Biological: rituximab

375 mg/m2, IV, Once per week for 3 weeks.

Other: Etoposide + G-CSF

Biological: filgrastim

10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide

Outcome Measures

Primary Outcome Measures

Correlate CD34+ cell yields with the addition of rituximab [At least two weeks prior to transplant]
Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF) [100 days post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria:
Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL)
Patients with B-cell NHL in first remission and who have significant risk for later relapse
Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation