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

November 28, 2011 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: William I. Bensinger, MD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion (Actual)

October 1, 2000

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

June 21, 2004

First Posted (Estimate)

June 22, 2004

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1488.00
  • FHCRC-1488.00
  • ELIGIX-C99-105
  • NCI-G00-1846
  • CDR0000068166 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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