- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00513175
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
7. november 2012 opdateret af: 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%.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding
44
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94143
- University of California San Francisco
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 75 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Charles A. Linker, M.D., University of California, San Francisco
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2001
Studieafslutning (Faktiske)
1. november 2007
Datoer for studieregistrering
Først indsendt
7. august 2007
Først indsendt, der opfyldte QC-kriterier
7. august 2007
Først opslået (Skøn)
8. august 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Nyre-neoplasmer
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Neoplasmer, Plasmacelle
- Leukæmi, lymfoid
- Leukæmi, B-celle
- Knoglemarvssvigtsforstyrrelser
- Neoplasmer
- Karcinom, nyrecelle
- Hæmatologiske neoplasmer
- Karcinom
- Myelomatose
- Leukæmi
- Leukæmi, myeloid
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Leukæmi, lymfatisk, kronisk, B-celle
- Anæmi
- Leukæmi, myelogen, kronisk, BCR-ABL positiv
- Myeloproliferative lidelser
- Anæmi, aplastisk
Andre undersøgelses-id-numre
- UC2101-CC01251
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Follikulært lymfom
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National Cancer Institute (NCI)Celgene CorporationAktiv, ikke rekrutterendeAnn Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymfom | Ann Arbor Stage II Grade 3 Non-Contiguous Follikulær... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetAnn Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymfom | Ann Arbor Stage II Grade 3 Non-Contiguous Follikulær... og andre forholdForenede Stater
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Portola PharmaceuticalsTrukket tilbageAITL | Perifert T-celle lymfom (PTCL NOS) | Nodale lymfomer af T Follicular Helper (TFH) | Follikulært T-celle lymfom (FTCL) | ALCL | HSTCL | EATL I,II | MEITL, EATL Type II | Nasal lymfom
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Mayo ClinicNational Cancer Institute (NCI)AfsluttetAnn Arbor Stage I Grade 1 Follikulært lymfom | Ann Arbor Stage I Grade 2 Follikulært lymfom | Ann Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetHIV-infektion | Tilbagevendende grad 3 follikulært lymfom | Plasmablastisk lymfom | Tilbagevendende diffust stort B-cellet lymfom | Primært effusionslymfom | AIDS-relateret primært effusionslymfom | Ann Arbor Stage I diffust stort B-cellet lymfom | Ann Arbor Stage II diffust stort B-cellet lymfom | Ann... og andre forholdForenede Stater