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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00274794
First received: January 10, 2006
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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 Intervention
Lymphoma
Biological: filgrastim
Biological: rituximab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Correlate CD34+ cell yields with the addition of rituximab [ Time Frame: At least two weeks prior to transplant ] [ Designated as safety issue: No ]
  • Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: February 2000
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Etoposide + G-CSF Biological: filgrastim
10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274794

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: Brian Bolwell, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00274794     History of Changes
Other Study ID Numbers: CASE-CCF-3600, P30CA043703, CASE-CCF-3600, CASE-CCF-0467
Study First Received: January 10, 2006
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
noncontiguous stage II adult Burkitt lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
recurrent adult lymphoblastic lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014