Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

April 8, 2020 updated by: University of Texas Southwestern Medical Center

A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia (CLL)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.

PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens.
  • Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens.
  • Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28.
  • Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150.

At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.

Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year.

Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

10

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5S 1A8
        • University of Toronto
      • Toronto, Ontario, Canada, M4S 1KN
        • Princess Margaret Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrament, Quebec
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Delaware
      • Newark, Delaware, United States, 19713
        • Delaware Clinical & Laboratory Physicians
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342-1601
        • Blood and Marrow Transplant Group of Georgia
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • University of Missouri Kansas City School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital and Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75235-8590
        • Simmons Cancer Center - Dallas
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Institute
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • Massey Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia or
  • Diagnosis of non-Hodgkin's lymphoma
  • Lymphoplasmacytic lymphoma
  • Grade I follicular small cleaved cell lymphoma
  • Grade II follicular mixed cell lymphoma
  • Diffuse small cleaved cell lymphoma
  • Small lymphocytic lymphoma
  • Relapsed after at least 1 course of prior therapy
  • Availability of a 6/6 human leukocyte antigen (HLA) A, B, and DR identical sibling donor
  • Nonmyeloablative transplantation candidate
  • No clinically significant effusions or ascites that would preclude administration of methotrexate

PATIENT CHARACTERISTICS:

-Age: 18 to 75

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-2 OR Zubrod 0-2
  • Life expectancy: At least 6 months
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin no greater than 3 mg/dL
  • Renal: Creatinine no greater than 2 mg/dL
  • Cardiovascular: left ventricular ejection fraction (LVEF) at least 40% on multigated acquisition (MUGA) scan or echocardiogram
  • Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) at least 50% of predicted

OTHER:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled bacterial, viral, fungal, or parasitic infection
  • Human Immunodeficiency Virus (HIV)1 and Human Immunodeficiency Virus (HIV)2 negative
  • No other active malignancy except basal cell skin cancer
  • No recent history of drug or alcohol abuse
  • No other primary disease or comorbid illness that would severely limit life expectancy

PRIOR CONCURRENT THERAPY

  • Biologic therapy:See Disease Characteristics
  • Biologic therapy:Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation
  • Biologic therapy:No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol
  • Chemotherapy: Not specified
  • Endocrine therapy: Not specified
  • Radiotherapy:Not specified
  • 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
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Study Chair: Robert H. Collins, MD, Simmons 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

October 1, 2001

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069462
  • UTSMC-0501228
  • AMGEN-UTSMC-0501228
  • IBMTR-SC-00-02.1
  • ROCHE-UTSMC-0501228
  • SPRI-UTSMC-0501228
  • NCI-V02-1706

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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