Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy

NCT01819558 — Phase 1 / Phase 2, Completed, 2 participants, Institut Paoli-Calmettes

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Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

Registry	NCT01819558, acronym ALLO-WT1
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	2 (Actual)
Sponsor	Institut Paoli-Calmettes (Other)
Conditions	Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
Interventions	recwt1-A10+AS01B (Biological)
Dates	start 2013-03-01, primary completion 2015-03-01, completion 2015-03-01, first posted 2013-03-27, last updated 2015-03-20
Locations	1 site in France

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
immune therapy	Experimental	Biological: recwt1-A10+AS01B	6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.

recwt1-A10+AS01B (Biological), also known as immune therapy

+Outcome measures

Primary outcomes

safety [30 days]: Dose limit toxicity (adverse event according to CTCAE V4.0)

Secondary outcomes

immune response [up to 60 weeks after treatment]: The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

1. Patients older than 18 and younger than 65 years.
2. Karnofsky ≥ 70 %.
3. 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.
4. Patients in morphologic complete remission at the time of transplantation.
5. WT1 expression detectable on tumor cells.
6. Expected life duration more than 6 months.
7. Creatinine clearance ≥ 50 ml/min
8. Bilirubinemia < 1.5N and ASAT < 2.5N.
9. 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).
10. Membership of a social security scheme or beneficiary of such a regime.
11. Signed inform consent.

Exclusion Criteria:

1. Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.
2. Pregnant or lactating women.
3. HIV seropositive patients.
4. Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)
5. Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
6. 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.
7. Previous history of another cancer, except if considered as probably cured by the investigator.
8. Patients deprived of liberty, or under guardianship.

+Locations (1)

Facility	City	Country	Status
Institut Paoli-Calmettes	Marseille	France

+Investigators

Didier BLAISE, MD PhD, Principal investigator, Institut Paoli-Calmettes