Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)
N/A
65 Years
Both
Lymphoma
Trial Information
Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)
OBJECTIVES:
- Determine the response rate of patients with AIDS-related lymphoma treated with
allogeneic peripheral blood stem cell (PBSC) transplantation followed by delayed donor
leukocyte infusion.
- Determine the complication rate of these patients treated with PBSC transplantation.
- Determine the immune dysfunction and recovery of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3. Patients who have not
received prior mediastinal radiotherapy receive thymic radiotherapy on day -1. Allogeneic
peripheral blood stem cells are infused on day 0. Patients also receive anti-thymocyte
globulin IV over 10-12 hours on days -1, 1, 3, and 5 and cyclosporine IV beginning on day
-1, switching to oral when possible, and tapering until day 35.
In the absence of active acute graft-versus-host disease (GVHD), and at least 2 weeks after
completion of cyclosporine, patients receive an infusion of donor leukocytes on or before
day 49. Patients may receive a second donor leukocyte infusion if there is evidence of
persistent malignancy and no GVHD.
Patients are followed through day 100, on days 120, 180, 270, and 365, and then every 6
months thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-4
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma
- Failed to achieve a complete remission with initial therapy OR
- Relapsed after initial therapy
- HIV-1 seropositive by Western Blot
- Measurable or evaluable (e.g., pleural fluid involvement) disease
- No leptomeningeal or parenchymal CNS involvement or active CNS leukemia
- HLA-A, B, or DR antigen matched or 1 antigen mismatched related donor available
- CD4 cell count greater than 100/mm3 (initial 12 patients) OR greater than 50/mm3
(subsequent patients)*
- HIV RNA less than 110,000 copies/mL* NOTE: *Unless not receiving optimal
anti-retroviral therapy as defined by current clinical standards
PATIENT CHARACTERISTICS:
Age:
- Physiologic 65 and under
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Estimated disease-free survival less than 1 year
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2 mg/dL
- Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)*
- SGOT or SGPT no greater than 3 times ULN*
- Hepatitis B surface antigen negative NOTE: *Unless receiving indinavir
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No angina pectoris
- No uncontrolled hypertension
- LVEF at least 45% by radionuclide ventriculography
Pulmonary:
- No severe chronic obstructive lung disease
- No symptomatic restrictive lung disease
- DLCO greater than 50% predicted
Other:
- No active uncontrolled infection
- No history of cytomegalovirus retinitis or pneumonitis, even if treated
- No other disease that would limit life expectancy
- No symptomatic leukoencephalopathy
- No neuropsychiatric abnormalities that would preclude transplantation
- Human T-cell lymphotrophic virus (HTLV-1) antibody negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 1 week since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent chronic suppressive therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
David T. Scadden, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000068894
NCT ID:
NCT00024128
Start Date:
August 2001
Completion Date:
March 2003
Related Keywords:
- Lymphoma
- AIDS-related peripheral/systemic lymphoma
- HIV-associated Hodgkin lymphoma
- Lymphoma
- Lymphoma, AIDS-Related
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