Tests ponatinib and blinatumomab in adults with Philadelphia-positive acute lymphoblastic leukemia
Tests ponatinib against imatinib, plus blinatumomab, in adults newly diagnosed with Philadelphia-positive leukemia.
Plain-language title generated from the registry record
Registry title: Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Key facts
- Where
- Aachen, Aschaffenburg, Augsburg, Bad Saarow, Bayreuth, Berlin, Bielefeld, Bochum, Bonn, Bremen, Brunswick, Chemnitz, Cologne, Cottbus, Darmstadt, Dessau-Rosslau, Dortmund, Dresden, Duesseldorf, Duisburg, Erlangen, Eschweiler, Essen, Frankfurt Am Main, Freiburg im Breisgau, Fulda, Georgsmarienhuette, Goch, Goettingen, Greifswald, Guetersloh, Hagen, Halle (Saale), Hamburg, Hamm, Hannover, Hanover, Heidelberg, Herne, Homburg, Idar-Oberstein, Jena, Karlsruhe, Kassel, Kiel, Koblenz, Leipzig, Luedenscheid, Magdeburg, Mainz, Mannheim, Marburg, Meschede, Moenchengladbach, Muenster, Munich, Nuremberg, Offenburg, Oldenburg, Paderborn, Passau, Potsdam, Regensburg, Rostock, Schwaebisch Hall, Stuttgart, Traunstein, Trier, Tuebingen, Ulm, Villingen-Schwenningen, Wuerzburg, Wuppertal, and Zwickau, GermanySee the 87 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06061094, who can take part
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Klinikum Aschaffenburg-Alzenau gGmbHAschaffenburg, GermanyTaking people
- Universitaetsklinikum AugsburgAugsburg, GermanyTaking people
- HELIOS Klinikum Bad Saarow GmbHBad Saarow, GermanyTaking people
- Klinikum Bayreuth GmbHBayreuth, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyTaking people
- Evangelisches Klinikum Bethel gGmbHBielefeld, GermanyTaking people
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbHBochum, GermanyTaking people
- Johanniter GmbHBonn, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
- Staedtisches Klinikum Braunschweig gGmbHBrunswick, GermanyTaking people
- Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
- University Hospital Cologne AöRCologne, GermanyTaking people
- Kommunale Traegergesellschaft Cottbus mbHCottbus, GermanyTaking people
- Klinikum Darmstadt GmbHDarmstadt, GermanyTaking people
- Staedtisches Klinikum DessauDessau-Rosslau, GermanyTaking people
- Kath. St. Paulus GmbHDortmund, GermanyTaking people
- Klinikum Dortmund gGmbHDortmund, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Marien Hospital Duesseldorf GmbHDuesseldorf, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- HELIOS Klinikum Duisburg GmbHDuisburg, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- St.-Antonius-Hospital gGmbHEschweiler, GermanyTaking people
- KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbHEssen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Klinikum Fulda gAGFulda, GermanyTaking people
- Franziskus Hospital HarderbergGeorgsmarienhuette, GermanyTaking people
- Katholisches Karl-Leisner KlinikumGoch, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- Universitaetsmedizin Greifswald KöRGreifswald, GermanyTaking people
- Klinikum Guetersloh gGmbHGuetersloh, GermanyTaking people
- Katholisches Krankenhaus Hagen gGmbHHagen, GermanyTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
- Asklepios Klinik St GeorgeHamburg, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Johanniter-Kliniken Hamm GmbHHamm, GermanyTaking people
- KRH Klinikum SILOAHHannover, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-RuhrHerne, GermanyTaking people
- Universitaet Des SaarlandesHomburg, GermanyTaking people
- Klinikum Idar-Oberstein GmbHIdar-Oberstein, GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, GermanyTaking people
- Vincentius-Diakonissen-Kliniken gAGKarlsruhe, GermanyTaking people
- Klinikum Kassel GmbHKassel, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Gemeinschaftsklinikum Mittelrhein gGmbHKoblenz, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- Maerkische Kliniken GmbHLuedenscheid, GermanyTaking people
- Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- Heidelberg UniversityMannheim, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Klinikum Hochsauerland GmbHMeschede, GermanyTaking people
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
- Klinikum NuernbergNuremberg, GermanyTaking people
- Ortenau KlinikumOffenburg, GermanyTaking people
- Klinikum Oldenburg AorOldenburg, GermanyTaking people
- Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbHPaderborn, GermanyTaking people
- Klinikum Passau Service GmbHPassau, GermanyTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbHRegensburg, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Diakonie-Klinikum Schwaebisch Hall gGmbHSchwaebisch Hall, GermanyTaking people
- Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus Und Paulinenhilfe gGmbHStuttgart, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
- Robert Bosch Gesellschaft fuer medizinische Forschung mbHStuttgart, GermanyTaking people
- Kliniken Suedostbayern AGTraunstein, GermanyTaking people
- Barmherzige Brueder Trier gGmbHTrier, GermanyTaking people
- Klinikum Mutterhaus der Borromaeerinnen gGmbHTrier, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbHVillingen-Schwenningen, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people
- Helios Universitaetsklinikum WuppertalWuppertal, GermanyTaking people
- Heinrich-Braun-Klinikum Zwickau gGmbHZwickau, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Goethe University
- Trial code
- NCT06061094EU 2024-517966-40-00
- Record updated
- 29 April 2025
- Original description
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.Read full original descriptionShow less
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)
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.
The EVOLVE trial aims to answer three questions challenging the current SoC:
Use of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).
In 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).
In 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).
Inclusion: Male or female patients >= 18 years, <=65 years; Philadelphia chromosome or BCR-ABL1 positive ALL; 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); ECOG performance status ≤2; Signed written inform consent; Molecular evaluation for BCR-ABL1 performed; Negative pregnancy test in women of childbearing potential; 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%); 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; 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; Normal QTcF interval ≤450 ms for males and ≤470 ms for females; Signed and dated written informed consent is available; Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL).
Exclusion: Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab; Patient previously treated with tyrosine kinase inhibitors; History of pancreatitis within 6 months previous to start of treatment within the trial; Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study; Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections; History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions; Known impaired cardiac function, including any of the following: as detailed in protocol; Symptomatic peripheral vascular disease; Any history of ischemic stroke or transient ischemic attacks (TIAs); History or active relevant autoimmune disease; Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation; Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C; 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; 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; Nursing women; Uncontrolled hypertriglyceridaemia; History or presence of clinically relevant CNS pathology as detailed in protocol; Inability to understand and/or unwillingness to sign a written informed consent.