RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Vaccines, Peptide for Acute Myeloid Leukemia, Adult

The aim of this Phase I study is to measure the immunogenicity along with safety and toxicity as well as first how well it works of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.

Official registry: https://clinicaltrials.gov/study/NCT06252584 · University Hospital Tuebingen · enrollment listed as 20

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vaccines, Peptide. The registry lists allocation as na. The aim of this Phase I study is to measure the immunogenicity along with safety and toxicity as well as first how well it works of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.

They plan to enroll about 20 people at Tübingen. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Multi-peptide Vaccination Adjuvanted With the TLR1/2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy

Interventions: Vaccines, Peptide

Primary outcome (registry wording): immunogenicity

Who it is for (from inclusion criteria)

Ages 18 Years to any
Males or females aged ≥18 years of age
Documented diagnosis of AML according to WHO guidelines
morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)
positive MRD is permitted
completion of previous intensive therapy (first vaccination 4-28 weeks after last application of chemotherapy) or
ongoing low intensity treatment with e.g. hypomethylating agents (HMA), venetoclax, etc
ongoing maintenance treatment with e.g. oral azacytidine or midostaurin is permitted

Who the registry excludes

Pregnant or breastfeeding
Unwilling or unable to follow the study schedule for any reason
Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted)
Concurrent or previous treatment within 28 days in another treatment clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints
Major surgery within 28 days of dosing of study drug
Treatment with immunotherapy agents within 28 days of dosing of study drug
Diagnosis of acute promyelocytic leukemia (APL)

Public study contact (from the registry)

Juliane Walz, Prof. Dr.

+49 7071 29

kketi@med.uni-tuebingen.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University Hospital Tuebingen — Tübingen, Baden-Wurttemberg, Germany (recruiting)

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FAQ about this NCT record

Is NCT06252584 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06252584?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06252584?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary