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

Phase 1

Completed

• Conditions: Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Biological: recwt1-A10+AS01B

• Registration Number: NCT01819558
• Lead Sponsor: Institut Paoli-Calmettes

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immune therapy	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.

Primary Outcome Measures

Name	Time	Method
safety	30 days	Dose limit toxicity (adverse event according to CTCAE V4.0)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France