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Randomized Trial of Autologous GVHD for Refractory Lymphoma


Phase 3
N/A
N/A
Open (Enrolling)
Both
Graft Versus Host Disease, Lymphoma

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Trial Information

Randomized Trial of Autologous GVHD for Refractory Lymphoma


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Georgia B. Vogelsang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066427

NCT ID:

NCT00003414

Start Date:

October 1997

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • 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 adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • graft versus host disease
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood 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
  • Graft vs Host Disease
  • Hodgkin Disease
  • Lymphoma

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410