Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy (ALLO-WT1)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome
• Intervention / Treatment: Biological: recwt1-A10+AS01B

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli-Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: recwt1-A10+AS01B; Other Names: immune therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	Dose limit toxicity (adverse event according to CTCAE V4.0)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• official web site of the sponsor

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: allograft; acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia; WT1 expression
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Precancerous Conditions; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: ALLO-WT1/IPC 2011-006