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Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL
Sponsor: PETHEMA Foundation
Summary
The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI). Efficay refers to the rate of Complete Molecular Response (BCR::ABL1/ABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections. Low-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase. Consolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.
Official title: Treatment Protocol for Newky Diagnosed Adult Ph-Chromosome Positive (BCR::ABL1) Acute Lymphoblastic Leukemia (LALPh2022)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2023-12-25
Completion Date
2030-12-25
Last Updated
2023-12-19
Healthy Volunteers
No
Interventions
Vincristine
dose 1.5 mg/m2 at days 1, 8, 15 and 22
Dexamethasone
40 mg on days 1-2, 8-9,15-16 and 22-23
Imatinib
600 mg per day from 1 to up to 5 years
Cytarabine
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
Mercaptopurine
50 mg/m2 on days 1 to 28 of maintenance
Methotrexate
1000 mg/m2 on day 1 of consolidation with 24h infusion; and 20 mg/m2 on days 1, 8, 15 and 22 of maintenance
Ponatinib
15 mg per day from consolidation start up to 5 years
allogeneic stem cell transplantation
Allogeneic stem cell transplantation from hematpoietic stem cells progenitors of familiar or not familiar origin. Cord blood transplantation can also be done.
Total body irradiation
Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)
Cyclophosphamide
60 mg/kg on days -6 and -5 before alloSCT
Fludarabine
30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)