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

NCT ID: NCT01819558

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Acute Myeloid Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

recwt1-A10+AS01B

Intervention Type: BIOLOGICAL

Interventions

recwt1-A10+AS01B

Intervention Type: BIOLOGICAL

Other Intervention Names

immune therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier BLAISE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli-Calmettes

Marseille, , France

Countries

France

Related Links

http://www.institutpaolicalmettes.fr/

official web site of the sponsor

Other Identifiers

ALLO-WT1/IPC 2011-006

Identifier Type: -

Identifier Source: org_study_id