Actively Recruiting
Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Led by Goethe University · Updated on 2025-04-29
220
Participants Needed
85
Research Sites
311 weeks
Total Duration
On this page
Sponsors
G
Goethe University
Lead Sponsor
D
Deutsche Leukämie- & Lymphom-Hilfe
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 65 years
- Diagnosis of Philadelphia chromosome or BCR-ABL1 positive acute lymphoblastic leukemia
- No prior treatment except corticosteroids for 7 days or less, standard prephase therapy, hydroxyurea, one dose of vincristine, Rituximab, or up to 5 days of Imatinib
- ECOG performance status of 2 or less
- Signed written informed consent
- Molecular evaluation for BCR-ABL1 performed
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential willing to use two highly effective contraception methods during treatment and for 3 months after
- Male participants with female partners of childbearing potential willing to use two highly effective contraception methods during treatment and for 3 months after
- Normal serum potassium and magnesium levels or corrected to normal before treatment
- Serum lipase less than or equal to 1.5 times upper limit of normal (ULN), or considered not clinically significant if slightly elevated
- Normal QTcF interval: 450 ms or less for males, 470 ms or less for females
- Participation in the German Multicenter Study Group for Adult ALL (GMALL) registry
You will not qualify if you...
- History of another malignancy within 5 years before starting therapy, except specific exceptions
- Contraindications to Imatinib, Ponatinib, chemotherapy, or Blinatumomab
- Prior treatment with tyrosine kinase inhibitors
- Nursing women
- Known impaired cardiac function or symptomatic peripheral vascular disease
- History of ischemic stroke or transient ischemic attacks
- Uncontrolled high triglycerides
- Significant central nervous system pathology
- Active or history of relevant autoimmune disease
- Known allergy to immunoglobulins or study drug components
- Known HIV infection or active Hepatitis B or C infections
- History of pancreatitis within 6 months before treatment start
- Participation in another clinical trial or investigational treatment within 30 days
- Liver function abnormalities beyond specified limits
- Total bilirubin above 1.5 times upper limit unless due to leukemia involvement or Gilbert's syndrome
- Severe uncontrolled acute or chronic infections
- Inability or unwillingness to provide informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 85 locations
1
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
2
Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
Actively Recruiting
3
Klinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
4
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
Actively Recruiting
5
Klinikum Bayreuth
Bayreuth, Germany, 95445
Actively Recruiting
6
Vivantes Klinikum am Urban
Berlin, Germany, 10967
Actively Recruiting
7
Charité Universitätsmedizin Berlin
Berlin, Germany, 12220
Actively Recruiting
8
Vivantes Klinikum Neukölln
Berlin, Germany, 12351
Actively Recruiting
9
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
10
Charite Berlin Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
11
Evangelisches Krankenhaus Bielefeld
Bielefeld, Germany, 33611
Actively Recruiting
12
UK Knappschaftskrankenhaus Bochum
Bochum, Germany, 44892
Actively Recruiting
13
Evangelische Kliniken Bonn
Bonn, Germany, 53113
Actively Recruiting
14
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
15
Städtisches Klinikum Braunschweig
Braunschweig, Germany, 38114
Actively Recruiting
16
Klinikum Bremen-Mitte
Bremen, Germany, 28205
Actively Recruiting
17
Klinikum Chemnitz
Chemnitz, Germany, 09116
Actively Recruiting
18
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
19
Klinikum Darmstadt
Darmstadt, Germany, 64283
Actively Recruiting
20
Städtisches Klinikum Dessau
Dessau, Germany, 06847
Actively Recruiting
21
Klinikum Dortmund
Dortmund, Germany, 44137
Actively Recruiting
22
St. Johannes Hospital Dortmund
Dortmund, Germany, 44137
Actively Recruiting
23
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
24
Helios Klinikum Duisburg
Duisburg, Germany, 47166
Actively Recruiting
25
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
26
Marien Hospital Düsseldorf
Düsseldorf, Germany, 40479
Actively Recruiting
27
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
28
St.-Antonius-Hospital
Eschweiler, Germany, 52249
Actively Recruiting
29
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
30
Evangelisches Krankenhaus Essen-Werden
Essen, Germany, 45239
Actively Recruiting
31
Department of Medicine, Hematology and Oncology, Goethe University Hospital Frankfurt
Frankfurt, Germany, 60580
Actively Recruiting
32
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
33
Niels-Stensen-Kliniken Georgsmarienhütte
Georgsmarienhütte, Germany, 49124
Actively Recruiting
34
Wilhelm-Anton-Hospital
Goch, Germany, 47574
Actively Recruiting
35
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Actively Recruiting
36
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Actively Recruiting
37
Klinikum Gütersloh
Gütersloh, Germany, 33332
Actively Recruiting
38
Katholisches Krankenhaus Hagen
Hagen, Germany, 58097
Actively Recruiting
39
Universitätsklinikum Halle
Halle, Germany, 06120
Actively Recruiting
40
Asklepios Klinik St. Georg Hamburg
Hamburg, Germany, 20099
Not Yet Recruiting
41
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
42
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
43
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
44
Marien Hospital Herne
Herne, Germany, 44625
Actively Recruiting
45
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Actively Recruiting
46
Klinikum Idar-Oberstein
Idar-Oberstein, Germany, 55743
Actively Recruiting
47
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
48
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Actively Recruiting
49
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, Germany, 76137
Actively Recruiting
50
Klinikum Kassel
Kassel, Germany, 34125
Actively Recruiting
51
Universitätsklinikum Kiel
Kiel, Germany, 24105
Actively Recruiting
52
Gemeinschaftsklinikum Mittelrhein
Koblenz, Germany, 56068
Actively Recruiting
53
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
54
Märkische Kliniken Lüdenscheid
Lüdenscheid, Germany, 58515
Actively Recruiting
55
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
56
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Not Yet Recruiting
57
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
58
Philipps-Universität Marburg
Marburg, Germany, 35043
Actively Recruiting
59
Kliniken Maria Hilf Möchengladbach
Möchengladbach, Germany, 41063
Actively Recruiting
60
LMU Klinikum München
München, Germany, 81377
Actively Recruiting
61
Klinikum Rechts der Isar TU München
München, Germany, 81675
Actively Recruiting
62
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
63
Klinikum Nürnberg
Nuremberg, Germany, 90419
Actively Recruiting
64
Ortenau Klinikum Offenburg
Offenburg, Germany, 77654
Actively Recruiting
65
Klinikum Oldenburg
Oldenburg, Germany, 26133
Actively Recruiting
66
Brüderkrankenhaus St. Josef Paderborn
Paderborn, Germany, 33098
Actively Recruiting
67
Klinikum Passau
Passau, Germany, 94032
Actively Recruiting
68
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Not Yet Recruiting
69
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany, 93049
Actively Recruiting
70
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
71
Universitätsklinikum Rostock
Rostock, Germany, 18057
Actively Recruiting
72
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), Germany, 27342
Actively Recruiting
73
Diakonie-Krankenhaus Schwäbisch-Hall
Schwäbisch Hall, Germany, 74523
Actively Recruiting
74
Katharinenhospital Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
75
Diakonissenkrankenhaus Stuttgart
Stuttgart, Germany, 70176
Actively Recruiting
76
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart, Germany, 70376
Actively Recruiting
77
Klinikum Traunstein
Traunstein, Germany, 83278
Actively Recruiting
78
Mutterhaus der Borromäerinnen Trier
Trier, Germany, 54290
Actively Recruiting
79
Krankenhaus d. Barmherzigen Brüder
Trier, Germany, 54292
Not Yet Recruiting
80
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
81
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
82
Klinikum Schwarzwald-Baar
Villingen-Schwenningen, Germany, 78052
Actively Recruiting
83
Helios Klinikum Wuppertal
Wuppertal, Germany, 42283
Actively Recruiting
84
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Actively Recruiting
85
Heinrich-Braun Klinikum
Zwickau, Germany, 08060
Actively Recruiting
Research Team
N
Nicola Goekbuget, MD
CONTACT
F
Fabian Lang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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