Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT

Recruiting now · Phase 2

Conditions studied: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

In brief

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).

Key facts

Study ID

NCT06061094

Run by

Goethe University

People needed

220

Starts

2023-07-14

Expected to finish

2029-07-01

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions
• Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab
• Patient previously treated with tyrosine kinase inhibitors
• Nursing women
• 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)
• Uncontrolled hypertriglyceridaemia
• History or presence of clinically relevant CNS pathology as detailed in protocol
• 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
• 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
• 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
• Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections
• Inability to understand and/or unwillingness to sign a written informed consent

Where it is running

• Klinikum Aschaffenburg — Aschaffenburg, Germany (enrolling)
• Klinikum Augsburg — Augsburg, Germany (enrolling)
• Helios Klinikum Bad Saarow — Bad Saarow, Germany (enrolling)
• Klinikum Bayreuth — Bayreuth, Germany (enrolling)
• Vivantes Klinikum am Urban — Berlin, Germany (enrolling)
• Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Vivantes Klinikum Neukölln — Berlin, Germany (enrolling)
• Helios Klinikum Berlin-Buch — Berlin, Germany (enrolling)
• Charite Berlin Virchow Klinikum — Berlin, Germany (enrolling)
• Evangelisches Krankenhaus Bielefeld — Bielefeld, Germany (enrolling)
• UK Knappschaftskrankenhaus Bochum — Bochum, Germany (enrolling)
• Evangelische Kliniken Bonn — Bonn, Germany (enrolling)
• Universitätsklinikum Bonn — Bonn, Germany (enrolling)
• Städtisches Klinikum Braunschweig — Braunschweig, Germany (enrolling)
• Klinikum Bremen-Mitte — Bremen, Germany (enrolling)
• Klinikum Chemnitz — Chemnitz, Germany (enrolling)
• Universitätsklinikum Köln — Cologne, Germany (enrolling)
• Klinikum Darmstadt — Darmstadt, Germany (enrolling)
• Städtisches Klinikum Dessau — Dessau, Germany (enrolling)
• Klinikum Dortmund — Dortmund, Germany (enrolling)
• St. Johannes Hospital Dortmund — Dortmund, Germany (enrolling)
• Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (enrolling)
• Helios Klinikum Duisburg — Duisburg, Germany (enrolling)
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany (enrolling)
• Uniklinik RWTH Aachen — Aachen, Germany (enrolling)

Full record on ClinicalTrials.gov

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