Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT06061094
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2023-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'C545373', 'term': 'ponatinib'}, {'id': 'C510808', 'term': 'blinatumomab'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2023-08-20', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Probability of remission duration', 'timeFrame': 'at 2 years, 3 years, 4 yrs', 'description': 'Probability of remission duration'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': 'at 2 years, 3 years, 4 yrs', 'description': 'Cumulative incidence of relapse'}, {'measure': 'Mortality in CR', 'timeFrame': 'at 2 years, 3 years, 4 yrs', 'description': 'Mortality in CR'}, {'measure': 'Probability of relapse-free survival', 'timeFrame': 'at 2 years, 3 years, 4 yrs', 'description': 'Probability relapse-free survival'}, {'measure': 'Hematologic/Molecular response', 'timeFrame': 'after induction I (3 weeks), after induction II (6 weeks) and after consolidation I (11 weeks)', 'description': 'Proportion of patients who achieve hematological and molecular remission or experience molecular failure'}, {'measure': 'Overall incidence and severity of AEs', 'timeFrame': 'during induction therapy (approximately 6 weeks)', 'description': 'Overall incidence and severity of AEs in patients (CTC-AE 4.0) receiving ponatinib versus imatinib during induction therapy'}, {'measure': 'Probability of continuous molecular remission', 'timeFrame': 'at 2, 3 and 4 yrs', 'description': 'Probability of continuous molecular remission at different time-points of Ponatinib versus Imatinib-based therapy'}, {'measure': 'Measuring log-reduction (kinetic on MRD response)', 'timeFrame': 'after induction I (3 wks), after induction II (6 wks) and after consolidation I (11 wks)', 'description': 'Measuring log-reduction (kinetic on MRD response) in patients with a Ponatinib versus Imatinib-based therapy'}, {'measure': 'Probability of MRD response including the induction of complete molecular remission and measurement the log-reduction of MRD', 'timeFrame': 'after induction I (3 weeks), after induction II (6 weeks) and after consolidation I (11 weeks)', 'description': 'Probability of MRD response including the induction of complete molecular remission and measurement the log-reduction of MRD in patients with blinatumomab in combination with Ponatinib versus Imatinib in patients with molecular persistence (molecular failure and MRD positivity below quantitative range) after consolidation 1'}, {'measure': 'Probability of continuous MRD response and molecular remission and duration of molecular remission', 'timeFrame': 'After consolidation 1 approximately every three months', 'description': 'Probability of continuous MRD response and molecular remission and duration of molecular remission at different time-points in patients with molecular persistence (molecular failure and not quantifiable) receiving Blinatumomab in combination with Ponatinib versus Imatinib after consolidation 1'}, {'measure': 'Overall incidence and severity of AEs in patients', 'timeFrame': 'during each treatment cycle', 'description': 'Overall incidence and severity of AEs in patients (CTC-AE 4.0) receiving Ponatinib or Imatinib in combination with Blinatumomab and chemotherapy'}, {'measure': 'Probability of continuous MRD response', 'timeFrame': 'at 2, 3 and 4 years', 'description': 'Probability of continuous MRD response and molecular remission and duration of molecular remission at different time-points in patients with Blinatumomab in combination with Ponatinib and chemotherapy or Imatinib and chemotherapy and rate of molecular relapse'}, {'measure': 'Time to molecular remission', 'timeFrame': 'after induction I (3 weeks), after induction II (6 weeks) and after consolidation I (11 weeks)', 'description': 'Time to molecular remission measured by time-point of first achievement'}, {'measure': 'Incidence of TKI dose reductions', 'timeFrame': 'for each cycle - approximately 28 days each - number of cycles depends on treatment arm'}, {'measure': 'Incidence of TKI changes', 'timeFrame': 'for each cycle - approximately 28 days each - number of cycles depends on treatment arm'}, {'measure': 'Incidence of TKI treatment interruptions', 'timeFrame': 'for each cycle - approximately 28 days each - number of cycles depends on treatment arm'}], 'primaryOutcomes': [{'measure': 'OS in MolCR patients treated with TKI-Chemo-Blina versus (vs) EOT with indication for SCT (Standard of Care)', 'timeFrame': 'up to 4 years from randomization I', 'description': 'Probability of overall survival up to 4 years from randomization I in patients with mo-lecular remission after consolidation 1 comparing a combination treatment of TKI, Blina-tumomab and chemotherapy versus EOT with indication for SCT'}], 'secondaryOutcomes': [{'measure': 'Rate of molecular complete remission at week 11 after consolidation', 'timeFrame': 'week 11 after consolidation', 'description': 'Rate of molecular complete remission at week 11 after consolidation with chemotherapy in combination with Ponatinb versus Imatinib'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia', 'Tyrosinekinase Inhibitors', 'Blinatumomab'], 'conditions': ['Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/38754400/', 'label': 'Lang et al, Oncol Res Treat 2024;47:430-433'}]}, 'descriptionModule': {'briefSummary': 'The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation.\n\nThe EVOLVE trial aims to answer three questions challenging the current SoC:\n\nUse of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).\n\nIn MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II).\n\nIn MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients \\>= 18 years, \\<=65 years\n* Philadelphia chromosome or BCR-ABL1 positive ALL\n* Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib)\n* ECOG performance status ≤2\n* Signed written inform consent\n* Molecular evaluation for BCR-ABL1 performed\n* Negative pregnancy test in women of childbearing potential\n* Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index \\<1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index \\<1%).\n* Normal serum levels \\> LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication\n* Serum lipase ≤ 1.5 x ULN. For serum lipase \\> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis\n* Normal QTcF interval ≤450 ms for males and ≤470 ms for females\n* Signed and dated written informed consent is available\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions\n* Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab\n* Patient previously treated with tyrosine kinase inhibitors\n* Nursing women\n* Known impaired cardiac function, including any of the following: as detailed in protocol\n* Symptomatic peripheral vascular disease\n* Any history of ischemic stroke or transient ischemic attacks (TIAs)\n* Uncontrolled hypertriglyceridaemia\n* History or presence of clinically relevant CNS pathology as detailed in protocol\n* History or active relevant autoimmune disease\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C\n* History of pancreatitis within 6 months previous to start of treatment within the trial\n* Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study\n* Inadequate hepatic functions defined as ASAT or ALAT \\> 2,5 times the institutional upper limit of normal or \\> 5 times ULN if considered due to leukemia\n* Total bilirubin \\> 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht\n* Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections\n* Inability to understand and/or unwillingness to sign a written informed consent'}, 'identificationModule': {'nctId': 'NCT06061094', 'acronym': 'GMALL-EVOLVE', 'briefTitle': 'Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'A Multicentre, Randomized Trial in Adults With de Novo Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia to Assess the Efficacy of Ponatinib Versus Imatinib in Combination With Low-intensity Chemotherapy, to Compare End of Therapy With Indication for SCT Versus TKI, Blinatumomab and Chemotherapy in Optimal Responders and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE)', 'orgStudyIdInfo': {'id': 'GMALL-EVOLVE'}, 'secondaryIdInfos': [{'id': '2022-000760-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: Imatinib + low dose chemotherapy', 'description': 'Imatinib 600mg QD + low dose chemotherapy induction and consolidation I (Standard Arm of Randomization I)', 'interventionNames': ['Drug: Imatinib']}, {'type': 'EXPERIMENTAL', 'label': 'B: Ponatinib + low dose chemotherapy', 'description': 'Ponatinib 45mg QD (reduction to 30mg QD after Induction) + low dose chemotherapy induction and consolidation I (Experimental Arm of Randomization I)', 'interventionNames': ['Drug: Ponatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C: Molecular CR: End of therapy with indication for SCT', 'description': 'Molecular CR: End of therapy with indication for SCT (Standard Arm of Randomization II)', 'interventionNames': ['Other: Indication for stem cell transplantation']}, {'type': 'EXPERIMENTAL', 'label': 'D: Molecular CR: continuation with Imatinib/Ponatinib (per Rando I), chemotherapy and Blinatumomab', 'description': 'Molecular CR: No end of therapy with indication for SCT but and continuation with Imatinib/Ponatinib (per Randomization I), chemotherapy and Blinatumomab (Experimental Arm of Randomization II)', 'interventionNames': ['Drug: Imatinib', 'Drug: Ponatinib', 'Drug: Blinatumomab']}, {'type': 'EXPERIMENTAL', 'label': 'E: Mol Fail / Mol NE: Continuation with Imatinib/Ponatinib (per Rando I) and addition of Blina', 'description': 'Molecular Failure / Molecular Not Evaluable: Continuation with Imatinib/Ponatinib (per Randomization I) and addition of Blinatumomab (Experimental Arm)', 'interventionNames': ['Drug: Imatinib', 'Drug: Ponatinib', 'Drug: Blinatumomab', 'Other: Indication for stem cell transplantation']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'description': 'Imatinib 600mg QD plus Chemotherapy', 'armGroupLabels': ['A: Imatinib + low dose chemotherapy', 'D: Molecular CR: continuation with Imatinib/Ponatinib (per Rando I), chemotherapy and Blinatumomab', 'E: Mol Fail / Mol NE: Continuation with Imatinib/Ponatinib (per Rando I) and addition of Blina']}, {'name': 'Ponatinib', 'type': 'DRUG', 'description': 'Ponatinib 45 mg QD plus chemotherapy', 'armGroupLabels': ['B: Ponatinib + low dose chemotherapy', 'D: Molecular CR: continuation with Imatinib/Ponatinib (per Rando I), chemotherapy and Blinatumomab', 'E: Mol Fail / Mol NE: Continuation with Imatinib/Ponatinib (per Rando I) and addition of Blina']}, {'name': 'Blinatumomab', 'type': 'DRUG', 'description': 'Patients with molecular failure or intermediate response receive one cycle Blinatumomab before SCT; Patients with molecular CR randomized to the experimental arm receive 3 cycles Blinatumomab + chemotherapy', 'armGroupLabels': ['D: Molecular CR: continuation with Imatinib/Ponatinib (per Rando I), chemotherapy and Blinatumomab', 'E: Mol Fail / Mol NE: Continuation with Imatinib/Ponatinib (per Rando I) and addition of Blina']}, {'name': 'Indication for stem cell transplantation', 'type': 'OTHER', 'description': 'Patients with molecular CR randomized to the standard arm have an indication for SCT; patients with molecular failure or intermediate response have an indication for SCT. SCT is not part of the trial.', 'armGroupLabels': ['C: Molecular CR: End of therapy with indication for SCT', 'E: Mol Fail / Mol NE: Continuation with Imatinib/Ponatinib (per Rando I) and addition of Blina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Uniklinik RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '63739', 'city': 'Aschaffenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Aschaffenburg', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '86156', 'city': 'Augsburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '15526', 'city': 'Bad Saarow', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Helios Klinikum Bad Saarow', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'zip': '95445', 'city': 'Bayreuth', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Bayreuth', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '10967', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Vivantes Klinikum am Urban', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12220', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12351', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Vivantes Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Helios Klinikum Berlin-Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charite Berlin Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33611', 'city': 'Bielefeld', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '44892', 'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'UK Knappschaftskrankenhaus Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53113', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Evangelische Kliniken Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '38114', 'city': 'Braunschweig', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Städtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '28205', 'city': 'Bremen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Bremen-Mitte', 'geoPoint': 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'RECRUITING', 'country': 'Germany', 'facility': 'St.-Antonius-Hospital', 'geoPoint': {'lat': 50.81854, 'lon': 6.27184}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45239', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Essen-Werden', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60580', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nicola Goekbuget, MD', 'role': 'CONTACT', 'email': 'goekbuget@em.uni-frankfurt.de', 'phone': '0049-6963016365'}, {'name': 'Fabian Lang, MD', 'role': 'CONTACT', 'email': 'fabian.lang@kgu.de', 'phone': '0049-69630183044'}], 'facility': 'Department of Medicine, Hematology and Oncology, Goethe University Hospital Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 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