- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01819558
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy (ALLO-WT1)
Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.
6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.
The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Marseille, Frankrike, 13009
- Institut Paoli-Calmettes
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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:
- Patients older than 18 and younger than 65 years.
- Karnofsky ≥ 70 %.
- Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
- Patients in morphologic complete remission at the time of transplantation.
- WT1 expression detectable on tumor cells.
- Expected life duration more than 6 months.
- Creatinine clearance ≥ 50 ml/min
- Bilirubinemia < 1.5N and ASAT < 2.5N.
- Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).
- Membership of a social security scheme or beneficiary of such a regime.
- Signed inform consent.
Exclusion Criteria:
- Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.
- Pregnant or lactating women.
- HIV seropositive patients.
- Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)
- Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
- Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.
- Previous history of another cancer, except if considered as probably cured by the investigator.
- Patients deprived of liberty, or under guardianship.
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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Eksperimentell: immune therapy
6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
safety
Tidsramme: 30 days
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Dose limit toxicity (adverse event according to CTCAE V4.0)
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30 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
immune response
Tidsramme: up to 60 weeks after treatment
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The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.
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up to 60 weeks after treatment
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ALLO-WT1/IPC 2011-006
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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