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

NCT ID: NCT00274794

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2006-05-31

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituxan + Etoposide + G-CSF

Group Type: OTHER

filgrastim

Intervention Type: BIOLOGICAL

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

rituximab

Intervention Type: BIOLOGICAL

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

Etoposide + G-CSF

Group Type: OTHER

filgrastim

Intervention Type: BIOLOGICAL

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

Interventions

filgrastim

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

Intervention Type: BIOLOGICAL

rituximab

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• Life expectancy at least 2 months
• Cardiac ejection fraction ≥ 45%
• DLCO ≥ 45%
• Creatinine < 2.0 mg/dL
• Bilirubin < 2.0 mg/dL
• AST < 2 times normal
• Platelet count ≥ 50,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Absolute lymphocyte count ≤ 10,000/mm^3
• HIV negative
• No severe medical or psychiatric illnesses
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• More than 8 weeks since prior rituximab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Principal Investigators

Brian J. Bolwell, MD

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute

Locations

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, United States

Countries

United States

References

Copelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. doi: 10.1038/bmt.2008.306. Epub 2008 Sep 15.

Reference Type: RESULT

PMID: 18794865 (View on PubMed)

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-3600

Identifier Type: -

Identifier Source: secondary_id

CASE-CCF-0467

Identifier Type: -

Identifier Source: secondary_id

CASE-CCF-3600

Identifier Type: -

Identifier Source: org_study_id