Clinical trial · Interventional
Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
Efficacy of Peptide (WT1) and Peptide(PRI) Vaccination for Patients With Low Risk Myeloid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells, combined with a substance called "MontanideTM". They are administered with granulocyte- macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune system respond to the vaccines. People 18 years of age or older with MDS, AML or CML may be eligible for this study. Participants receive six injections of the vaccines, one dose every other week for a total of 10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate injection of GM-CSF is given in the same area as the vaccine injections. Subjects are observed for 2 hours after the first vaccination and at least 30 minutes after each subsequent vaccination for allergic reactions. In addition to the vaccination, subjects undergo the following: * History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy before starting the vaccinations. * Safety monitoring during vaccine administration (every other week for 10 weeks) with blood tests and check of vital signs. * Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray at week 12 and bone marrow biopsy visit 16.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF (Sargramostim) | Drug | — | UNRESOLVED |
| Montanide adjuvant | Biological | — | UNRESOLVED |
| PR1:169-177 Peptide | Biological | — | UNRESOLVED |
| WT1:126-134 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers
- description
- Subjects were given 6 subcutaneous injects of PR1:169-177 in "Montanide" adjuvant and 6 subcutaneous injections of WT1:126-134 in "Montanide" adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.
- interventionNames
- Biological: WT1:126-134
- Biological: PR1:169-177 Peptide
- Drug: GM-CSF (Sargramostim)
- Biological: Montanide adjuvant
Primary outcomes (1)
- measure
- Number of Participants Who Experienced Inducing or Boosting of a Cellular Immune Response
- timeFrame
- 16 weeks
- description
- Number of participants diagnosed with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML) who experienced an inducing or boosting of a cellular immune response following Wilm's Tumor 1 (WT1) and PR1 vaccine. A T-cell immune response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Diagnosed with MDS (B subtypes Refractory anemia (RA), Refractory anemia with ring sideroblasts (RARS) -Low Risk) (MDS with 5q- must have failed lenalidomide or been ineligible to receive it) OR Diagnosed with AML and in complete remission within 5 years of treatment with less than 5% marrow blasts OR Diagnosed with CML in chronic phase Unsuitable for stem cell transplantation (SCT) (age over sixty or unavailability of a fully-matched donor) or made an informed decision not to undergo the transplant procedure or are between 6 months 3 years following allogeneic SCT and fulfill the following criteria: 100% donor engraftment, Less than 5% blasts in marrow normal marrow cellularity Human leukocyte antigen (HLA-A020 1) positive at one allele Ages 18-85 years old Off all lympho-ablative chemotherapeutic agents EXCLUSION CRITERIA: * Hypoplastic MDS * Relapsed AML * CML in accelerated phase or blast crisis * Hypocellular bone marrow (less than 20%) * History of Wegener's granulomatosis * Serologic antibody against proteinase-3 (ANCA positive) * Previous allergic reaction to Montanide Adjuvant * Positive test for HIV * Treatment with systemic corticosteroids or immunosuppressants within 14 days prior to study entry * Co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy * Predicted survival less than 28 days * Pregnant or breast feeding (All female patients must have a urine pregnancy test within 1 week prior to vaccine administration) * Unwilling to practice abstinence or effective contraception (men and women) during the study period. * Enrolled in another drug or vaccine clinical trial during the study period * Inability to comprehend the investigational nature of the study and provide informed consent
References
Publications (1)
- RESULTRezvani K, Yong AS, Mielke S, Jafarpour B, Savani BN, Le RQ, Eniafe R, Musse L, Boss C, Kurlander R, Barrett AJ. Repeated PR1 and WT1 peptide vaccination in Montanide-adjuvant fails to induce sustained high-avidity, epitope-specific CD8+ T cells in myeloid malignancies. Haematologica. 2011 Mar;96(3):432-40. doi: 10.3324/haematol.2010.031674. Epub 2010 Dec 6. PMID 21134985