An observational study in Lymphoblastic Leukemia, Philadelphia-Positive ALL and Adult ALL, sponsored by PETHEMA Foundation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by PETHEMA Foundation · Observational
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.
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 each 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 induction phase with vincristine (dose 1.5 mg/m2 at days 1, 8, 15 and 22), dexamethasone (dose 40 mg days 1-2, 8-9,15-16 and 22-23) will be given together with the TKI imatinib (dose 600 mg from day to consolidation start) to all patients of all ages as induction to remission phase.
Consolidation treatment will continue with low-dose chemotherapy with methotrexate (dose 1000 mg/m2 on day 1 with 24h infusion) and arabinoside of cytarabine (dose 1000 mg/m2/ days 1, 3 and 5 with 2h infusion) with imatinib (dose 600 mg per day) if the patient fullfills both criteria: i) to show a measurable residual disease (MRD) value \<0,01% at 3 month of therapy, and ii) not showing IKZF1plus genetics.
Those patients having any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy (same as described above) plus ponatinib (dose 30 mg per day) as TKI and allogeneic stem cell transplantation (alloSCT) followed by maintenance chemotherapy with mercaptopurine (dose 50 mg/m2 on days 1 to 28) and methotrexate (dose 20 mg/m2 on days 1, 8, 15 and 22) together with imatinib (dose 600 mg per day) or ponatinib (15 mg per day) up to 5 years. The remaining patients (standard-risk) will receive maintenance chemotherapy (as described above) together with imatinib (dose 600 mg per day) or ponatinib (15 mg per day) up to 5 years and will not be submitted to alloSCT.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 or over years with newly diagnosed Ph-positive or BCR::ABL1-positive acute lymphoblastic leukemia (Ph+ ALL).
Exclusion Criteria:
Patients in Complete Remission and Complete Molecular Response at end Induction therapy will receive consolidation with imatinib (or dasatinib if intolerance) and chemotherapy, unless they show the IKZF1plus genotype, which will imply switch to the not complete molecular response or high-risk genetics (IKZ1plus) group.
Drug: Vincristine · Drug: Dexamethasone · Drug: Imatinib · Drug: Cytarabine · Drug: Mercaptopurine · Drug: Methotrexate
Patients in Complete Remission and without Complete Molecular Response at the end of Induction therapy or showing the IKZF1plus genotype, will receive consolidation treatment with ponatinib and chemotherapy followed by allogeneic stem cell transplantation and maintenance therapy.
Drug: Vincristine · Drug: Dexamethasone · Drug: Imatinib · Drug: Cytarabine · Drug: Mercaptopurine · Drug: Methotrexate · Drug: Ponatinib · Procedure: allogeneic stem cell transplantation · Procedure: Total body irradiation · Drug: Cyclophosphamide · Drug: Fludarabine
dose 1.5 mg/m2 at days 1, 8, 15 and 22
40 mg on days 1-2, 8-9,15-16 and 22-23
600 mg per day from 1 to up to 5 years
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
50 mg/m2 on days 1 to 28 of maintenance
1000 mg/m2 on day 1 of consolidation with 24h infusion; and 20 mg/m2 on days 1, 8, 15 and 22 of maintenance
15 mg per day from consolidation start up to 5 years
Allogeneic stem cell transplantation from hematpoietic stem cells progenitors of familiar or not familiar origin. Cord blood transplantation can also be done.
Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)
60 mg/kg on days -6 and -5 before alloSCT
30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)
Overall survival
Improvement of OS compared to that observed in the previous protocols (PETHEMA LALPh08 and LALOPh07).
Time frame: 5 Years
Change the complete molecular response (CMR) rate with Ponatinib
Change the CMR rate at the end of consolidation with the administration of ponatinib to those patients who do not achieve CMR at the end of induction or have high-risk genetics (IKZF1plus).
Time frame: 5 Years
Limit the number of alloTPH compared to that observed in the previous protocols (PETHEMA LALPh08 and LALOPh07).
Limit the number of alloTPH to any of the following: * Lack of CMR at the end of consolidation. * High-risk genetics (IKZF1plus).
Time frame: 5 Years
Maintenance
To assess the number of non-transplanted participants who receive maintenance treatment.
Time frame: 5 Years
Treatment with TKI after HSCT
To assess the number of transplanted patients who receive TKI maintenance treatment preemptively (upon of MRD\>0.01%).
Time frame: 5 Years
Assess the frequency and degree of Adverse Events
Assess the frequency of cytopenias and degree. Assess the frequency of infections and degree. Assess the frequency of vascuar events and degree. Assess the frequency of hepatic events and degree. Assess the frequency of pancreatic events and degree.
Time frame: 5 Years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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PETHEMA Foundation