Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005787

Enrollment

Registered

2003-01-27

Start date

1999-09-30

Completion date

2002-01-31

Last updated

2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Neutropenia

Keywords

neutropenia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Brief summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant. PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

Detailed description

OBJECTIVES: * Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma. * Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy. * Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo. * Determine the relationships between length of culture, immunophenotype, and clinical outcome. * Determine the required numbers of white blood cell precursors for clinical efficacy. * Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period. OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0. Patients are followed monthly for 1 year. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Interventions

BIOLOGICALepoetin alfa

BIOLOGICALfilgrastim

BIOLOGICALrecombinant flt3 ligand

BIOLOGICALrecombinant interleukin-3

BIOLOGICALsargramostim

PROCEDUREin vitro-treated peripheral blood stem cell transplantation

Study design

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

17 Years to 65 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically proven relapsed or refractory non-Hodgkin's lymphoma * Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation * No metastatic disease involving the bone marrow PATIENT CHARACTERISTICS: Age: * 17 to 65 Performance status: * ECOG 0 or 1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * No active hepatitis B or C * Bilirubin less than 2.5 times normal\* * SGOT or SGPT less than 2.5 times normal\* * Alkaline phosphatase less than 2.5 times normal NOTE: \* Unless Gilbert's syndrome present Renal: * Creatinine clearance greater than 50 mL/min Cardiovascular: * Cardiac ejection fraction normal Pulmonary: * DLCO at least 50% predicted * FEV\_1 and FVC at least 75% predicted Other: * HIV negative * Not pregnant * Negative pregnancy test * No non-neoplastic disease that would preclude intensive chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * No prior external beam radiotherapy to more than 25% of the active bone marrow Surgery: * Not specified

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026