Status:
COMPLETED
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01819558
Start Date
March 1 2013
End Date
March 1 2015
Last Update
March 20 2015
Active Locations (1)
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1
Institut Paoli-Calmettes
Marseille, France, 13009