- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: David T. Scadden, MD, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Lymfom, AIDS-relatert
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Enzymhemmere
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Dermatologiske midler
- Antifungale midler
- Calcineurin-hemmere
- Cyklofosfamid
- Antilymfocyttserum
- Syklosporin
- Syklosporiner
Andre studie-ID-numre
- AMC-028
- CDR0000068894 (Annen identifikator: NCI)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på cyklofosfamid
-
The Christie NHS Foundation TrustAvsluttetCD19 Positivt Non-Hodgkin lymfomStorbritannia
-
Uprety ShraddhaPostgraduate Institute of Medical Education and ResearchUkjent
-
Yonsei UniversityFullførtBrystkreftKorea, Republikken
-
National Institute of Blood and Marrow Transplant...UkjentAplastisk anemi IdiopatiskPakistan
-
Lagos State UniversityUkjentHematologisk abnormitetNigeria
-
University of Alabama at BirminghamGenentech, Inc.; Ortho Biotech, Inc.FullførtInvasiv brystkreftForente stater
-
German Breast GroupGerman Adjuvant Breast Cancer GroupFullført
-
Auxilio Mutuo Cancer CenterUkjentInfiltrerende kanal- og lobulært karsinom in situ | Invasiv lobulært brystkarsinom | Inflammatorisk brystkarsinomPuerto Rico
-
Memorial Sloan Kettering Cancer CenterFullførtNon-Hodgkins lymfom | CNS lymfom | CNS hjernekreftForente stater