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

NCT01819558 | Completed Phase 1 DMC

• 1 other identifier: ALLO-WT1/IPC 2011-006
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

acute myeloid leukemia; chronic myeloid leukemia; myelodysplastic syndrome; allograft; WT1 expression

Outcome Measures

Primary Outcomes (1)

• safety

  Dose limit toxicity (adverse event according to CTCAE V4.0)

  30 days

Secondary Outcomes (1)

• immune response

  up to 60 weeks after treatment

Study Arms (1)

immune therapy

EXPERIMENTAL

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

Interventions

recwt1-A10+AS01B BIOLOGICAL

Also known as: immune therapy

immune therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Related Links

• official web site of the sponsor

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes

Interventions

Immunotherapy, Active

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Didier BLAISE, MD PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

FR (1)