- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00024128
Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma
Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: David T. Scadden, MD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Lymfom, AIDS-relateret
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Dermatologiske midler
- Antifungale midler
- Calcineurin-hæmmere
- Cyclofosfamid
- Antimfocyt serum
- Cyclosporin
- Cyclosporiner
Andre undersøgelses-id-numre
- AMC-028
- CDR0000068894 (Anden identifikator: NCI)
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