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

NeuroTherapia, Inc.

Status: Completed

Conditions: Lymphoma

Treatments: Biological: rituximab; Biological: filgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00274794

CASE-CCF-3600

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-0467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 2 patient groups

Rituxan + Etoposide + G-CSF

Other group

Treatment:

Biological: rituximab

Biological: filgrastim

Etoposide + G-CSF

Other group

Treatment:

Biological: filgrastim