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

Acute Myeloid Leukemia Clinical Trial

— ALLO-WT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819558
• Other study ID #: ALLO-WT1/IPC 2011-006
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 19, 2013
• Last updated: March 19, 2015
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Biological:
• recwt1-A10+AS01B

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety	Dose limit toxicity (adverse event according to CTCAE V4.0)	30 days	Yes
Secondary	immune response	The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.	up to 60 weeks after treatment	No

External Links

•   official web site of the sponsor