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

Primary Purpose

Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
recwt1-A10+AS01B
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, allograft, WT1 expression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Paoli-Calmettes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immune therapy

Arm Description

6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

immune response
The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.

Full Information

First Posted
March 19, 2013
Last Updated
March 19, 2015
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT01819558
Brief Title
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
Acronym
ALLO-WT1
Official Title
Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
Keywords
acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, allograft, WT1 expression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immune therapy
Arm Type
Experimental
Arm Description
6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.
Intervention Type
Biological
Intervention Name(s)
recwt1-A10+AS01B
Other Intervention Name(s)
immune therapy
Primary Outcome Measure Information:
Title
safety
Description
Dose limit toxicity (adverse event according to CTCAE V4.0)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
immune response
Description
The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.
Time Frame
up to 60 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier BLAISE, MD PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr/
Description
official web site of the sponsor

Learn more about this trial

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

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