Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Bl… (NCT03480438) | Clinical Trial Compass
CompletedPhase 2
Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab
Germany52 participantsStarted 2018-06-01
Plain-language summary
The trial proposed here attempts to reduce induction chemotherapy to phase I of standard induction in patients with B-precursor ALL. Induction phase II will be replaced by blinatumomab.
The initial treatment phase is followed by sequential chemotherapy and further blinatumomab cycles.
Who can participate
Age range56 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with newly diagnosed CD19 positive B-precursor ALL
✓. Greater than 25 % blasts in bone marrow
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
✓. Charlson comorbidity score \<= 2
✓. Age \> 55 and \< 75 years at the time of informed consent
✓. Renal and hepatic function as defined below:
✓. Negative pregnancy test in women of childbearing potential
✓. Ability to understand and willingness to sign a written informed consent
Exclusion criteria
✕. Antileukemic pretreatment (GMALL prephase with dexamethasone and cyclophosphamide allowed)
✕. History of malignancy other than ALL within 5 years prior to start of protocol-specified therapy with the exception of:
✕. History or presence of clinically relevant (per investigator's assessment) CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
✕. Active ALL in the CNS confirmed by CSF analysis) or testes (clinical diagnosis) or other extramedullary involvement; non-bulky lymph node (\< 7.5 cm diameter) involvement will be accepted
What they're measuring
1
Hematologic and MRD response after induction therapy
Timeframe: after induction therapy (up to 8 weeks)