Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Low- or Intermediate-Grade Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00006241
First received: September 11, 2000
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Treating the peripheral stem cells in the laboratory to remove any existing cancer cells may improve the effectiveness of the transplant.

PURPOSE: Randomized phase II trial to compare the effectiveness of treated peripheral stem cells with that of untreated stem cells in patients who have relapsed low- or intermediate-grade non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: chemotherapy
Procedure: in vitro-treated peripheral blood stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pivotal Study to Determine the Safety and Efficacy of Using B-Cell High Density Microparticles (BCell-HDM) to Deplete B-Cells From Peripheral Blood Stem Cell Collections Without Compromising the Time to Neutrophil and Platelet Engraftment in Patients With Relapsed Low or Intermediate Grade B-Cell Non-Hodgkin's Lymphoma Given Autologous Peripheral Blood Stem Cell Transplants After High-Dose Chemotherapy

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: March 2000
Study Completion Date: October 2000
Detailed Description:

OBJECTIVES: I. Determine the effectiveness of the B-cell high density microparticles (BCell-HDM) device in purging B-cells from peripheral blood stem cells (PBSC) harvested from patients with relapsed low or intermediate grade B-cell non-Hodgkin's lymphoma. II. Determine the recovery of T-cells and CD34+ cells in BCell-HDM processed PBSC in these patients. III. Compare hematopoietic engraftment following infusion of autologous PBSC purged using the BCell-HDM device versus unpurged autologous PBSC in these patients receiving high dose chemotherapy. IV. Determine the toxicity of this regimen in these patients. V. Determine the occurrence of adverse effects from this regimen in these patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by grade of lymphoma (low vs intermediate), type of myeloablative conditioning regimen (chemotherapy only vs chemotherapy/total body irradiation), and center. Patients are randomized to one of two treatment arms. Patients undergo peripheral blood stem cell (PBSC) harvest over no more than 4 consecutive days. A myeloablative conditioning regimen of either chemotherapy alone or chemotherapy/total body irradiation is given within 4 weeks of PBSC harvest. Prior to randomization one patient at each center receives PBSC transplantation using cells purged with the B-cell high density microparticle (BCell-HDM) device. Arm I: Patients receive BCell-HDM treated PBSC transplantation on day 0. Arm II: Patients receive untreated PBSC transplantation on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed on days 30 and 100, and then at 6 and 12 months.

PROJECTED ACCRUAL: A total of 115 patients (15 for prerandomization study, 50 for each treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of relapsed low or intermediate grade B-cell non-Hodgkin's lymphoma CD20+ or CD19+ tumor cells Bone marrow involvement less than 20% of intratrabecular space All tumor masses less than 5 cm in each dimension In second or greater remission with either complete remission or minimal disease state OR Failed to achieve remission with primary induction therapy, but can achieve minimal disease with additional chemotherapy or radiotherapy OR Persistent splenomegaly with otherwise minimal disease No active CNS involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 50% predicted Other: Not pregnant Negative pregnancy test No prior other malignancy except carcinoma in situ of the cervix or basal cell carcinoma of the skin No known hypersensitivity to nickel No known hypersensitivity to mouse proteins HIV negative HTLV I and II negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior unconjugated anti-B-cell monoclonal antibody (mAb) (e.g., rituximab, Campath I) No prior anti-B-cell mAb conjugated to radioisotopes such as iodine I 131 (e.g., iodine I monoclonal antibody anti-B1) or yttrium Y No concurrent mAb therapy until 12 months after study No other biologic therapy (e.g., monoclonal antibodies, interferon alfa) for 12 months after study No concurrent hematopoietic growth factors other than filgrastim (G-CSF) Chemotherapy: See Disease Characteristics No chemotherapy within 5 days prior to PBSC collection No other concurrent chemotherapy for 12 months after study Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy for 12 months after study Surgery: Not specified

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006241

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006241     History of Changes
Other Study ID Numbers: 1488.00, FHCRC-1488.00, ELIGIX-C99-105, NCI-G00-1846, CDR0000068166
Study First Received: September 11, 2000
Last Updated: November 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
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 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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014