Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 See Disease Characteristics
 Prior chemotherapy allowed

Endocrine therapy:
 Not specified   

Radiotherapy:
 Not specified   

Surgery:
 Not specified   

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

Expected Enrollment

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

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.

Bolaños-Meade J, Garrett-Mayer E, Luznik L, et al.: Induction of autologous graft-versus-host disease: results of a randomized prospective clinical trial in patients with poor risk lymphoma. Biol Blood Marrow Transplant 13 (10): 1185-91, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Georgia Vogelsang, MD, Protocol chair		Ph: 410-955-8464 Email: vogelge@jhmi.edu

Registry Information
Official Title		Randomized Trial of Autologous GVHD for Refractory Lymphoma
Trial Start Date		1997-10-14
Registered in ClinicalTrials.gov		NCT00003414
Date Submitted to PDQ		1998-07-02
Information Last Verified		2007-09-27
NCI Grant/Contract Number		CA15396, CA06973

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