Status:
RECRUITING
Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Lead Sponsor:
Goethe University
Collaborating Sponsors:
Deutsche Leukämie- & Lymphom-Hilfe
German Federal Ministry of Education and Research
Conditions:
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06061094
Start Date
July 14 2023
End Date
July 1 2029
Last Update
April 29 2025
Active Locations (85)
Enter a location and click search to find clinical trials sorted by distance.
1
Uniklinik RWTH Aachen
Aachen, Germany, 52074
2
Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
3
Klinikum Augsburg
Augsburg, Germany, 86156
4
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526