Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06061094
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06061094
Study Brief:
Protocol Section:
NCT06061094