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Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia

7. november 2012 oppdatert av: University of California, San Francisco
The primary objective of this study is to examine transplant related mortality (TRM) at 100 days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall survival >50%.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering

44

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • San Francisco, California, Forente stater, 94143
        • University of California San Francisco

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 75 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia

Beskrivelse

Inclusion Criteria:

  • <75 years old
  • Availability of suitable matched unrelated donor. We will require HLA matching at 9 of 10 loci including HLA A, B, C, DR and DQ. For patients treated at UCSF, typing will be done in the UCSF Immunogenetics Department. Typing will be done by high-resolution techniques at the allele level. Donors will be recruited through the National Marrow Donor Program (NMDP). Donors must meet the standards of NMDP as well as Institutional standards for donors at the center for which they are being collected.
  • Disease must be stable or responding to therapy. The expected time to disease progression should be greater than 12 weeks.
  • Disease types include:

    • Acute myeloid leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (-7, -7q, -5, -5q, complex, Ph+), evolution from prior myelodysplasia or AML secondary to prior chemotherapy, failure to achieve remission, or second or subsequent remission. To ensure adequate time until disease progression, marrow blasts must be <10%. This may be achieved using chemotherapy treatment.
    • Myelodysplasia with high-risk features. These will include adverse cytogenetics (-7, -7q, -5, -5q, complex), excess blasts, prior conversion to AML, or severe cytopenias, with ANC<500uL or platelets <20,000uL. Marrow blasts must be <10%. This may be achieved using chemotherapy.
    • Acute lymphoblastic leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (Ph+, 11q23 abnormalities, and monosomy 7), patients requiring more than one induction course to achieve remission, as well as patients failing to enter remission or in second or subsequent remission. Marrow blasts must be <10%.
    • Chronic lymphocytic leukemia with high-risk features. This will include refractoriness to initial or subsequent therapy, progression after initial response to therapy, or prolymphocytic (PLL) morphology.
    • Follicular lymphoma with high-risk features. This will include refractoriness to initial or subsequent therapy, progression after response to initial therapy, or > or equal 3 IPI risk factors.
    • Multiple myeloma, stage II-III. Patients are eligible either at diagnosis or after initial progression.
    • Other lymphomas including diffuse large cell lymphoma, mantle cell lymphoma, or Hodgkin's disease which as failed to respond to primary therapy, progressed or recurred after prior therapy.
    • Myeloproliferative diseases (myelofibrosis, polycythemia vera essential thrombocytosis) with evidence of disease acceleration.
    • Chronic myeloid leukemia with failure disease control by Imatinib.
    • Renal cell carcinoma with metastatic disease
    • Aplastic anemia not responsive to immunosuppressive therapy
  • Laboratory requirements (within 2 weeks of entry, EF and DLCO within 4 weeks): --Creatinine ,2.0mg/dL and creatinine clearance >40 mL/min

    • Bilirubin <3mg/dL, AST <4x upper limit of normal. Patients with elevated total bilirubin who are suspected of having Gilbert's Disease will be eligible if the direct bilirubin is normal.
    • Patients with hepatitis C and hepatitis B are eligible if bilirubin and AST meet above criteria
    • Cardiac ejection fraction >30%
    • DLCO >40% predicted
    • Negative pregnancy test (for females of reproductive age)
  • Absence of uncontrolled active infection.
  • Prior stem cell (or bone marrow) transplantation is permitted
  • Signed informed consent

Exclusion Criteria:

  • Active infection requiring ongoing antibiotic treatment
  • Poor performance status
  • Rapid progression of malignant disease
  • Opinion of BMT Committee that autologous transplant would be a preferable form of treatment
  • Organ function below requirements
  • Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Charles A. Linker, M.D., University of California, San Francisco

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2001

Studiet fullført (Faktiske)

1. november 2007

Datoer for studieregistrering

Først innsendt

7. august 2007

Først innsendt som oppfylte QC-kriteriene

7. august 2007

Først lagt ut (Anslag)

8. august 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. november 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. november 2012

Sist bekreftet

1. november 2012

Mer informasjon

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. .