Patient-individualized Peptide Vaccination Based on Tumor-specific Mutations in Children and Young Adults With Primary/Relapsed ALL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03559413|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary/Relapsed Acute Lymphoblastic Leukemia (ALL) of Childhood, Adolescents and Young Adults||Biological: Individual peptide vaccination with adjuvant GM-CSF and Imiquimod||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
|Experimental: Intervention group||
Biological: Individual peptide vaccination with adjuvant GM-CSF and Imiquimod
Intradermal injection of a cocktail of 3-5 individual HLA-binding peptides. Subcutaneous injection of adjuvant GM-CSF at vaccination site. Topical administration of Imiquimod at vaccination site.
- Primary endpoint is "success of treatment" defined as a patient showing a vaccination-induced T-cell response without unacceptable toxicity and acute GvHD of Grade III or higher or extensive chronic GvHD until day 120 (after 10 vaccinations). [ Time Frame: 120 days ]Side effects wil be assessed according to NCI common toxicity criteria V4.0. GvHD will be graded according to Glucksberg criteria. A vaccine-specific response will be defined by an at least 2-fold elevated cytokine expression of CD4+ and/or CD8+ T cells over background in response to stimulation with the vaccine peptides. A vaccine-induced response will be defined by an at least 2-fold elevated response at a certain timepoint compared to pre-vaccination.
- To evaluate CD4+ and/or CD8+ T-cell responses over the vaccination period. [ Time Frame: 246 days ]T-cell responses will be measured after completion of the study at day 246 and will be analyzed with regard to the T-cell responses at day 120.
- To evaluate changes in minimal residual disease (MRD) during and after treatment. [ Time Frame: 246 days ]Possible reduction of MRD levels on days 36, 120 and 246 (after 7, 10 and 16 vaccinations) measured as reduction of 1 log compared to baseline yes/no.
- To evaluate the relapse rate during and after treatment. [ Time Frame: 246 days ]Relapse rates will be assessed on days 120 and 246.
- To evaluate the event-free survival (EFS) during and after treatment. [ Time Frame: 246 days ]EFS will be assessed on days 120 and 246.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559413
|Contact: Peter Lang, Prof. Dr.||+firstname.lastname@example.org|
|Contact: Armin Rabsteyn, Dr. rer. email@example.com|
|University Medical Center for Children and Adolescents Heidelberg||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Contact: Olaf Witt, Prof. Dr. +496221 423272 firstname.lastname@example.org|
|University Children's Hospital Tübingen||Recruiting|
|Tübingen, Baden-Württemberg, Germany, 72076|
|Contact: Peter Lang, Prof. Dr. +497071-2983781 email@example.com|
|Contact: Armin Rabsteyn, Dr. rer. nat. +497071-2981644 firstname.lastname@example.org|
|University Children's Hospital Munich, Center for Pediatric Hematology and Oncology||Recruiting|
|München, Bayern, Germany, 80337|
|Contact: Tobias Feuchtinger, Prof. Dr. +4989-440052759 email@example.com|
|University Hospital Düsseldorf, Clinic for Pediatric Oncology, Hematology and Clinical Immunology||Recruiting|
|Düsseldorf, Nordrhein-Westfalen, Germany, 40225|
|Contact: Roland Meisel, Prof. Dr. +49211-8118907 firstname.lastname@example.org|
|Charite Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology||Recruiting|
|Berlin, Germany, 13353|
|Contact: Christiane Chen-Santel, Dr. med. +4930-450566074 email@example.com|
|Principal Investigator:||Peter Lang, Prof. Dr.||University Children’s Hospital Tuebingen|