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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


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlate CD34+ cell yields with the addition of rituximab

Outcome Time Frame:

At least two weeks prior to transplant

Safety Issue:

No

Principal Investigator

Brian J. Bolwell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CASE-CCF-3600

NCT ID:

NCT00274794

Start Date:

February 2000

Completion Date:

May 2006

Related Keywords:

  • Lymphoma
  • 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
  • recurrent grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • splenic marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Cleveland Clinic Taussig Cancer InstituteCleveland, Ohio  44195