Acute Myeloid LeukemiaPhase 2NCT00153582
WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
A Phase 2 study testing WT1 126-134 peptide in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- WT1 126-134 peptide
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to not given
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML or myelodysplastic syndromes (MDS)
- Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
- HLA-A2+
- WT1-expression in bone marrow
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hematology&Oncology Charité CBF
Berlin, 12200
Ulrich Keilholz, MD, +49-30-8445-3906, ulrich.keilholz@charite.de
Ulrich Keilholz, MD
About this study
Official title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.
Read the detailed description
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- WT1 126-134 peptide
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WT1 126-134 peptideBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of T cell response
Secondary outcomes (2)
Clinical outcome
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Keilholz, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153582
- Sponsor's protocol ID
- HaemaCBFWT102
- Other IDs
- Carreras 04/25f
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 22 Feb 2006
- Results posted
- No
Publications
Mailander V, Scheibenbogen C, Thiel E, Letsch A, Blau IW, Keilholz U. Complete remission in a patient with recurrent acute myeloid leukemia induced by vaccination with WT1 peptide in the absence of hematological or renal toxicity. Leukemia. 2004 Jan;18(1):165-6. doi: 10.1038/sj.leu.2403186. No abstract available.
PubMed 14603333
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
- ClinicalTrials.gov ID
- NCT00153582
- Acronym / sponsor ID
- HaemaCBFWT102
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2002
- First posted
- 12 Sep 2005 (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.
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.
Detailed description
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AML or myelodysplastic syndromes (MDS)
- Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
- HLA-A2+
- WT1-expression in bone marrow
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| WT1 126-134 peptide | Biological | – |
Primary outcome
Generation of T cell response
2 secondary outcomes
Clinical outcome
Safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
- Results publication: PubMed 14603333Mailander V, Scheibenbogen C, Thiel E, Letsch A, Blau IW, Keilholz U. Complete remission in a patient with recurrent acute myeloid leukemia induced by vaccination with WT1 peptide in the absence of hematological or renal toxicity. Leukemia. 2004 Jan;18(1):165-6. doi: 10.1038/sj.leu.2403186. No abstract available.
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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.
Ulrich Keilholz, MD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WT1 126-134 peptide in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Feb 2006. 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 Germany. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Scheibenbogen, MD (+49-30-8445-4576, carmen.scheibenbogen@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of T cell response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153582, which also lists 1 linked publication.
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 22 Feb 2006.