Skip to main content
OpenTrials
Completed

NCT Number: NCT00003414

Graft-Versus-Host Disease in Treating Patients With Recurrent or Refractory Lymphoma or Hodgkin's Disease

RATIONALE: Cyclosporine may induce graft-versus-host disease and make the body build an immune response that will kill cancer cells. Interleukin-2 and interferon gamma may enhance the effectiveness of graft-versus-host disease to kill cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of graft-versus-host disease in treating patients who have recurrent or refractory lymphoma or Hodgkin's disease .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graft Versus Host Disease Burkitt Lymphoma Chronic Disease DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence Tumor Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

OBJECTIVES: I. Determine whether autologous graft versus host disease significantly alters the relapse rate for lymphoma or Hodgkin's disease after autologous bone marrow transplantation.

OUTLINE: This is a randomized study. Stem cells are harvested and cryopreserved. All patients receive busulfan/cyclophosphamide or cyclosporine/total body irradiation as a preparative regimen. Arm I: Patients randomized to the graft versus host disease (GVHD) induction arm receive oral cyclosporine twice a day beginning on day 0 and continuing for at least 28 days, followed by peripheral blood stem cell (PBSC) infusion. At the time the white blood cell count begins to recover, subcutaneous interferon gamma is administered for 10 doses, followed 2 days later by subcutaneous interleukin-2 (IL-2) for 18 doses. Arm II: Patients do not receive autologous GVHD therapy after the PBSC transplant. Both arms should receive radiation to the site of lymphoma after recovering from the stem cell transplantation. Patients are followed at 6 months, 1 year, and 2 years posttransplant.

PROJECTED ACCRUAL: Approximately 50 patients (25 per arm) will be accrued for this study within 3 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Patients receiving autologous or syngeneic peripheral blood stem cell transplants for chemotherapy refractory or recurrent lymphoma or Hodgkin's disease, including: Progressive disease within 6 weeks of completing initial induction therapy OR Failure to achieve at least an overall partial response (at least a 50% reduction in tumor size) to conventional salvage therapy following relapse

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: No capillary leak syndrome Hepatic: Bilirubin no greater than 5 mg/dL Renal: Creatinine less than 4 mg/dL No renal failure requiring dialysis Cardiovascular: No hypotension No severe venooclusive disease Pulmonary: No pulmonary infiltrates OR No requirement for greater than 2 L oxygen Other: No weight gain greater than 5% of baseline weight No concurrent sepsis No temperature of 39 degrees C or higher for two or more days No clinically evident ascites

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Treatment and study plan

aldesleukin

Biological

recombinant interferon gamma

Biological

busulfan

Drug

Cyclophosphamide

Drug

cyclosporine

Drug

peripheral blood stem cell transplantation

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Relapse rate for lymphoma after autologous transplant

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Trial of Autologous GVHD for Refractory Lymphoma

Important dates

Study start
1997
Primary completion
2004
Study completion
2004
First posted
Dec 2, 2003
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.