NCT03559413CompletedPhase 1/2
Patient-individualized Peptide Vaccination Based on Tumor-specific Mutations in Children and Young Adults With Primary/Relapsed ALL
Prospective Phase I/II Study: Patient-individualized Peptide Vaccination Based on Whole Exome Sequencing With Adjuvant GM-CSF (Granulocyte Macrophage Colony-stimulating Factor) in Children and Young Adults With Primary/Relapsed Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 4 Dec 2023
Brief summary (registry, in English)
The aim of this clinical study is to evaluate the feasibility and safety of an individualized peptide vaccination approach in patients with acute lymphoblastic leukemia (ALL). For this purpose, tumor-specific mutations are analyzed by comparative exome sequencing of tumor and healthy reference tissue. Expression of variants is further validated by RNA sequencing. In a second step, HLA-binding (human leukocyte antigen-binding) peptides derived from mutated protein sequences are selected for vaccination. The peptides are administered as a vaccination cocktail with adjuvant GM-CSF and Imiquimod over a course of 9 months and a total of 16 vaccinations. Primary objective is the de novo induction of a specific T cell response without unacceptable toxicity and acute GvHD (graft versus host disease).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Jun 2018
- Start date
- Jun 2016
- Primary completion date
- Mar 2022
- Lead sponsor
- University Children's Hospital Tuebingen
- NCT number
- NCT03559413
- EudraCT number
- 2015-005281-29
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From Jun 2016 to the primary completion date, Mar 2022
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for immunosuppressive drugs.
Other illness
- Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukoencephalopathy.
- Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia).
Lab values
- Ejection fraction \<25%; Creatinine-clearance \<40ml/min; Bilirubin \>4mg/dl, Transaminases \>400 units/ml; severe infection (HIV, Hepatitis), acute GvHD III-IV or chronic GvHD.
Other
- Frank relapse (\>5% leukemic blasts).
- No tumor material available for exome sequencing.
Who the study is looking for
- Pediatric patients and young adults with ALL (T, B, pro-B, pre-B or c-ALL) ≥CR3 or with ≥1st relapse after stem cell transplantation (SCT); or patients in ≤CR2 who have received SCT without having reached a sufficient molecular remission prior to, or after SCT (defined as MRD ≥10\^-4); or patients with initially refractory disease to standard treatment who could proceed to stem cell transplantation with alternative treatment options.
- Hematological remission has to be reached (\<5% blasts in bone marrow or detectable minimal residual disease (MRD) ≤5x10\^-2) after salvage chemotherapy and/or subsequent SCT.
Age in the registry: 1 year to 30 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité-Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Hospital Düsseldorf, Clinic for Pediatric Oncology, Hematology and Clinical Immunology Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| University Medical Center for Children and Adolescents Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| University Children's Hospital Munich, Center for Pediatric Hematology and Oncology Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| University Children's Hospital Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.