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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068894 | Other Identifier | NCI |
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Withdrawn prior to initiation.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Donor 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. Treatment with donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | |||
| therapeutic allogeneic lymphocytes | Biological | |||
| cyclophosphamide | Drug | |||
| cyclosporine | Drug | |||
| peripheral blood stem cell transplantation | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| David T. Scadden, MD | Massachusetts General Hospital | Study Chair |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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