Acute Myeloid LeukemiaPhase 1/2ALLO-WT1NCT01819558
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
A Phase 1/2 study testing recwt1-A10+AS01B in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- recwt1-A10+AS01B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Mar 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- recwt1-A10+AS01B
- Keywords
- acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, allograft, WT1 expression
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recwt1-A10+AS01BBiological
Also called immune therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: recwt1-A10+AS01B |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Dose limit toxicity (adverse event according to CTCAE V4.0)
Measured: 30 days
Secondary outcomes (1)
immune response
The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.
Measured: up to 60 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier BLAISE, MD PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819558
- Sponsor's protocol ID
- ALLO-WT1/IPC 2011-006
- Acronym
- ALLO-WT1
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2013
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
- ClinicalTrials.gov ID
- NCT01819558
- Acronym / sponsor ID
- ALLO-WT1 / ALLO-WT1/IPC 2011-006
- Keywords
- acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, allograft, WT1 expression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immune therapy | Experimental | Biological: recwt1-A10+AS01B6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recwt1-A10+AS01BAlso: immune therapy | Biological | immune therapy |
Primary outcome
safety
Time frame: 30 days
Dose limit toxicity (adverse event according to CTCAE V4.0)
1 secondary outcome
immune response
Time frame: up to 60 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- official web site of the sponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier BLAISE, MD PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recwt1-A10+AS01B in people with Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.