- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00714259
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35249-6979
- University of Alabama in Birmingham BMT/CT Program Outpatient Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Stage II or III non-progressive disease Multiple Myeloma.
- CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
- ≤ 70 years old.
- Eligible and willing HLA matched related donor.
- Bilirubin <2xULN.
- ALT and AST <3xULN.
- LVEF > 40%.
- Creatinine Clearance >40mL/min.
- Pulmonary function DLCO corrected to ≥ 70%.
- Minimum performance score of 70%.
- Platelet count >130 x103 micro L.
- LDH ≤1.5xULN.
- No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
- No uncontrolled infections.
Exclusion Criteria:
- Age >70 years old.
- Performance status <70%.
- Uncontrolled infections or is HIV positive
- Prior malignancies that are felt to have a <80% probability of being cured.
- Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
- Prior Allograft
- History of rapidly growing disease at diagnosis or at any progression or have MDS.
- No eligible and willing HLA matched donor.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Non Myeloablative Treatment
Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
Fludarabine 30 mg/m2/day x 3 days
TBI 200cGy x1 dose on transplant day
On Day 0 pts will received an infusion of HLA matched sibling donor stem cells.
Dose is determined by the volume of cells obtained from donor.
Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progressive Free Survival Post Transplant
Tidsramme: 100 days post transplant
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subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
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100 days post transplant
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Progressive Free Survival Post Transplant
Tidsramme: 180 days post transplant
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Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
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180 days post transplant
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Progressive Free Survival Post Transplant
Tidsramme: 365 days post transplant
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Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
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365 days post transplant
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Progression Free Survival Post Transplant
Tidsramme: 2 years post transplant
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Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
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2 years post transplant
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Non-relapse Treatment Related Mortality
Tidsramme: Within 100 days post transplant
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Death related to treatment without relapse within 100 days after transplant
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Within 100 days post transplant
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Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Tidsramme: Post transplant up to 100 days post transplant
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Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
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Post transplant up to 100 days post transplant
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Composite Incidence of Acute and Chronic Graft Versus Host Disease
Tidsramme: Up to 100 days post transplant.
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Up to 100 days post transplant.
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: William P. Vaughan, MD, University of Alabama in Birmingham
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Neoplasmer, plasmacelle
- Leukemi, lymfoid
- Leukemi
- Leukemi, B-celle
- Neoplasmer
- Lymfom
- Multippelt myelom
- Lymfom, mantelcelle
- Leukemi, lymfatisk, kronisk, B-celle
- Antineoplastiske midler
- Fludarabin
Andre studie-ID-numre
- F080429003
- UAB-0775 (Annen identifikator: UAB Cancer Center study number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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. .
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