- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00897260
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Medicin: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Stråling: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital, Leukemia/BMT Program of BC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital or the BCCA-Vancouver.
Eligible patients will have one of the following underlying diseases:
- High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC >100x109/L) or failure to achieve a complete remission after standard induction therapy.
- Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics or failure to achieve complete remission after standard induction therapy. ALL or AML in second or subsequent remission
- Myelofibrosis with myeloid metaplasia.
- Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated phase.
- Myelodysplastic syndrome with IPSS risk category >Int-1
- Aplastic anemia
- Non-Hodgkin's lymphoma, chronic lymphocytic leukemia or Hodgkin's disease in relapse or second or subsequent remission.
- Multiple Myeloma
- No active central nervous system (CNS) disease.
- No 9/10 or better HLA antigen matched related donor or VUD available.
- The patient's condition precludes waiting to search and find a VUD in the Unrelated Donor Registries
- Acceptance of standard blood product support
- Adequate organ function as defined by current Leukemia/BMT Program of BC standards (Appendix 10.1)
- Karnofsky performance status ≥ 80 (Appendix 10.2)
Exclusion Criteria:
- Active infection
- Pregnancy
- Significant psychiatric disorder
- Progressive disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
|
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis. DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
UCB Infusion
DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To determine the 100-day treatment related mortality (TRM), complete remission rate and the 2-year progression free and overall survival rate for patients under going this treatment.
Tidsramme: 100 days
|
100 days
|
|
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
Tidsramme: 1 year
|
1 year
|
|
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
Tidsramme: 1 year
|
1 year
|
|
To determine rate of hematologic engraftment following umbilical cord blood transplantation with 1-2 cord blood units using total body irradiation & fludarabine as transplant conditioning regimen & cyclosporine/MMF as graft-vs-host disease prophylaxis
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Donna Hogge, University of British Columbia - Vancouver Coastal Health Research Institute
Publikationer og nyttige links
Hjælpsomme links
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H08-02813
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