Therapeutic Vaccinations with p210 Peptides in Imatinib-Treated Chronic Myeloid Leukemia Patients: 10 Years Follow-Up of GIMEMA CML0206 and SI0207 Studies
Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIM...
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| Published in | Vaccines (Basel) Vol. 13; no. 4; p. 419 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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16.04.2025
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| Abstract | Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: “immunization phase” (six vaccinations every 2 weeks); “reinforcement” phase (three monthly boosts) and “maintenance” phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant. Results: The short-term results (at completion of vaccine protocol—12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months. Conclusions: The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered. |
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| AbstractList | We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients.
: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: "immunization phase" (six vaccinations every 2 weeks); "reinforcement" phase (three monthly boosts) and "maintenance" phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant.
: The short-term results (at completion of vaccine protocol-12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months.
: The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered. Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: “immunization phase” (six vaccinations every 2 weeks); “reinforcement” phase (three monthly boosts) and “maintenance” phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant. Results: The short-term results (at completion of vaccine protocol—12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months. Conclusions: The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered. Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: "immunization phase" (six vaccinations every 2 weeks); "reinforcement" phase (three monthly boosts) and "maintenance" phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant. Results: The short-term results (at completion of vaccine protocol-12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months. Conclusions: The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered.Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods: From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: "immunization phase" (six vaccinations every 2 weeks); "reinforcement" phase (three monthly boosts) and "maintenance" phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant. Results: The short-term results (at completion of vaccine protocol-12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months. Conclusions: The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered. Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell responses in chronic myeloid leukemia (CML) patients. Methods : From 2007 to 2011, two multicenter peptide vaccine phase II studies, GIMEMA CML0206 and SI0207, enrolling overall 109 CML patients (68 b3a2 and 41 b2a2) with persistence of molecular disease during imatinib treatment, were carried out. Peptide vaccination schedule included the following: “immunization phase” (six vaccinations every 2 weeks); “reinforcement” phase (three monthly boosts) and “maintenance” phase (two boosts at 3-month intervals). GM-CSF (granulocyte-macrophage-colony-stimulating factor, sarmograstim) served as the immunological adjuvant. Results : The short-term results (at completion of vaccine protocol—12 months) and long-term follow-up are reported. All patients completed the vaccination schedule with no toxicity. After vaccinations, the BCR::ABL1 peptide-specific CD4+ T-cell response was documented in 80% of patients. In the short term, 30% of patients achieved a reduction in BCR::ABL1, while the majority showed stable molecular disease with fluctuations. The median follow-up since diagnosis and last vaccination are 18 and 10 years, respectively, with an overall survival (OS) rate at 18 years of 89%. In addition, 97/109 (89%) patients are alive, while 12/109 (11%) died of CML-unrelated reasons. Overall, 18/109 (16.5%) patients are in treatment-free remission (TFR) for a median time of 48 months. Conclusions : The long-term results of p210 peptide vaccinations in CML patients with persisting disease during imatinib treatment showed its feasibility, safety, absence of off-targets events, high OS and not negligible rate of successful TFR. Active immunotherapeutic approaches in CML patients with low disease burden, eventually employing newer vaccine strategies such as mRNA vaccines, may be reconsidered. |
| Audience | Academic |
| Author | Galimberti, Sara Piciocchi, Alfonso Defina, Marzia Abruzzese, Elisabetta Rughini, Arianna Russo Rossi, Antonella Patriarca, Andrea Cafarelli, Cristiana Iuliano, Francesco Rege Cambrin, Giovanna Malagola, Michele Sicuranza, Anna Cencini, Emanuele Bocchia, Monica Lunghi, Monia Castagnetti, Fausto Niederwieser, Dietger Sammartano, Vincenzo Vucinic, Vladan Malato, Alessandra Luciano, Luigiana Intermesoli, Tamara D’Adda, Mariella Pacelli, Paola Gugliotta, Gabriele Cartocci, Alessandra Breccia, Massimo |
| AuthorAffiliation | 11 Department of Clinical and Experimental Sciences, University of Brescia, Unit of Blood Diseases and Bone Marrow Transplant, ASST Spedali Civili, 25123 Brescia, Italy; michele.malagola@unibs.it 9 Division of Internal Medicine and Hematology, San Luigi Gonzaga Hospital, 10043 Turin, Italy; giovanna.rege@libero.it 5 Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont and AOU Maggiore della Carità, 28100 Novara, Italy; monia.lunghi@med.uniupo.it (M.L.); andrea.patriarca@uniupo.it (A.P.) 2 Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy; breccia@bce.uniroma1.it 6 Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy; tintermesoli@asst-pg23.it 10 Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, University Hospital Leipzig, 04103 Leipzig, Germany; vladan.vucinic@medizin.uni-leipzig.de (V.V.); dietger.niederwieser@medizin.uni-leipzig.de (D.N.) 16 Departm |
| AuthorAffiliation_xml | – name: 10 Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, University Hospital Leipzig, 04103 Leipzig, Germany; vladan.vucinic@medizin.uni-leipzig.de (V.V.); dietger.niederwieser@medizin.uni-leipzig.de (D.N.) – name: 11 Department of Clinical and Experimental Sciences, University of Brescia, Unit of Blood Diseases and Bone Marrow Transplant, ASST Spedali Civili, 25123 Brescia, Italy; michele.malagola@unibs.it – name: 13 Division of Hematology, S. Eugenio Hospital, 00144 Rome, Italy; elisabetta.abruzzese@uniroma2.it – name: 5 Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont and AOU Maggiore della Carità, 28100 Novara, Italy; monia.lunghi@med.uniupo.it (M.L.); andrea.patriarca@uniupo.it (A.P.) – name: 15 Section of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy; sara.galimberti@unipi.it – name: 2 Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy; breccia@bce.uniroma1.it – name: 6 Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy; tintermesoli@asst-pg23.it – name: 7 Hematology Unit “Federico II”, University of Naples, 80138 Naples, Italy; lulucian@unina.it – name: 14 Division of Hematology, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy; marielladadda@libero.it – name: 1 Hematology Unit, Azienda Ospedaliera Universitaria Senese, University of Siena, 53100 Siena, Italy; marziadefina@libero.it (M.D.); vincenzo.sammartano2@gmail.com (V.S.); cristianacafarelli21@gmail.com (C.C.); cencioema@libero.it (E.C.); paola.pacelli@unisi.it (P.P.); monica.bocchia@unisi.it (M.B.) – name: 8 Hematology and Stem Cell Transplantation Unit, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari “Aldo Moro”, 70121 Bari, Italy; antonella.russorossi@gmail.com – name: 9 Division of Internal Medicine and Hematology, San Luigi Gonzaga Hospital, 10043 Turin, Italy; giovanna.rege@libero.it – name: 16 Department of Medical Sciences, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy; alessandra.cartocci@dbm.unisi.it – name: 4 Institute of Hematology “L. and A. Seràgnoli”, Department of Experimental, Diagnostic and Specialty Medicine, “S. Orsola-Malpighi” University Hospital, University of Bologna, 40138 Bologna, Italy; gabriele.gugliotta@unibo.it (G.G.); fausto.castagnetti@unibo.it (F.C.) – name: 3 Presidio Ospedaliero N. Giannetasio, Azienda ASL 3, 87068 Rossano, Italy; iuliano54@outlook.it – name: 17 GIMEMA Foundation, 00182 Rome, Italy; a.piciocchi@gimema.it (A.P.); a.rughini@gimema.it (A.R.) – name: 12 A.O. Ospedali Riuniti Villa Sofia-Cervello-P.O. Cervello, 90146 Palermo, Italy; alessandramalato@hotmail.com |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40333294$$D View this record in MEDLINE/PubMed |
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| Snippet | Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific... We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific T-cell... Background: We previously showed that peptides encompassing the unique b3a2 or b2a2 breakpoint amino-acid sequence of oncogenic p210 induced peptide-specific... |
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| SubjectTerms | Amino acids Cancer vaccines CD4 antigen Cell growth Chronic myeloid leukemia CML Colony-stimulating factor Drug therapy Granulocyte-macrophage colony-stimulating factor Health aspects Imatinib immune therapy Immunization Immunology Kinases Leukemia Leukocytes (granulocytic) Lymphocytes Lymphocytes T Macrophages mRNA Myeloid leukemia Patient outcomes peptide Peptides Remission Schedules Toxicity vaccine Vaccines |
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| Title | Therapeutic Vaccinations with p210 Peptides in Imatinib-Treated Chronic Myeloid Leukemia Patients: 10 Years Follow-Up of GIMEMA CML0206 and SI0207 Studies |
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