Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL
NCT ID: NCT06175702
Last Updated: 2023-12-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
150 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-12-25
Study Completion Date
2030-12-25
Brief Summary
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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.
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.
Detailed Description
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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.
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.
Conditions
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Lymphoblastic Leukemia
Philadelphia-Positive ALL
Adult ALL
Keywords
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Acute Lymphoblastic Leukemia
Philadelphia (BCR::ABL1) positive
Adults
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Not complete molecular response or high-risk genetics (IKZF1plus)
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.
Vincristine
Intervention Type
DRUG
dose 1.5 mg/m2 at days 1, 8, 15 and 22
Dexamethasone
Intervention Type
DRUG
40 mg on days 1-2, 8-9,15-16 and 22-23
Imatinib
Intervention Type
DRUG
600 mg per day from 1 to up to 5 years
Cytarabine
Intervention Type
DRUG
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
Mercaptopurine
Intervention Type
DRUG
50 mg/m2 on days 1 to 28 of maintenance
Methotrexate
Intervention Type
DRUG
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
Intervention Type
DRUG
15 mg per day from consolidation start up to 5 years
allogeneic stem cell transplantation
Intervention Type
PROCEDURE
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
Intervention Type
PROCEDURE
Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)
Cyclophosphamide
Intervention Type
DRUG
60 mg/kg on days -6 and -5 before alloSCT
Fludarabine
Intervention Type
DRUG
30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)
Complete molecular response and low risk genetics
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.
Vincristine
Intervention Type
DRUG
dose 1.5 mg/m2 at days 1, 8, 15 and 22
Dexamethasone
Intervention Type
DRUG
40 mg on days 1-2, 8-9,15-16 and 22-23
Imatinib
Intervention Type
DRUG
600 mg per day from 1 to up to 5 years
Cytarabine
Intervention Type
DRUG
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
Mercaptopurine
Intervention Type
DRUG
50 mg/m2 on days 1 to 28 of maintenance
Methotrexate
Intervention Type
DRUG
1000 mg/m2 on day 1 of consolidation with 24h infusion; and 20 mg/m2 on days 1, 8, 15 and 22 of maintenance
Interventions
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Vincristine
dose 1.5 mg/m2 at days 1, 8, 15 and 22
Intervention Type
DRUG
Dexamethasone
40 mg on days 1-2, 8-9,15-16 and 22-23
Intervention Type
DRUG
Imatinib
600 mg per day from 1 to up to 5 years
Intervention Type
DRUG
Cytarabine
1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion
Intervention Type
DRUG
Mercaptopurine
50 mg/m2 on days 1 to 28 of maintenance
Intervention Type
DRUG
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
Intervention Type
DRUG
Ponatinib
15 mg per day from consolidation start up to 5 years
Intervention Type
DRUG
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.
Intervention Type
PROCEDURE
Total body irradiation
Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)
Intervention Type
PROCEDURE
Cyclophosphamide
60 mg/kg on days -6 and -5 before alloSCT
Intervention Type
DRUG
Fludarabine
30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.
2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).
3. Performance status 0-2; patients with performance status\>2 attributable to ALL can be included.
4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \<2 mg/dl or creatinine clearance \> 30 ml/min (except altered renal function attributable to ALL); normal heart function: EF ventricular \> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.
2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).
3. Performance status 0-2; patients with performance status\>2 attributable to ALL can be included.
4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \<2 mg/dl or creatinine clearance \> 30 ml/min (except altered renal function attributable to ALL); normal heart function: EF ventricular \> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.
Exclusion Criteria
1. Any other subtype of ALL.
2. Patients with chronic liver disease.
3. Patients with chronic respiratory failure.
4. Renal failure not due to ALL.
5. Lipase and amylase\>1.5× ULN.
6. Patients with positive HIV serology.
7. Serious neurological alterations not due to ALL.
8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.
9. Pregnant or breastfeeding women.
10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \>450 mg/dL.
2. Patients with chronic liver disease.
3. Patients with chronic respiratory failure.
4. Renal failure not due to ALL.
5. Lipase and amylase\>1.5× ULN.
6. Patients with positive HIV serology.
7. Serious neurological alterations not due to ALL.
8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.
9. Pregnant or breastfeeding women.
10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \>450 mg/dL.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Josep M Ribera Santasusana, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Catala d'Oncologia-Hospital Universitari Germans Trias i Pujol
Central Contacts
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References
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Ribera JM, Garcia O, Oriol A, Gil C, Montesinos P, Bernal T, Gonzalez-Campos J, Lavilla E, Ribera J, Brunet S, Martinez MP, Tormo M, Genesca E, Barba P, Sarra J, Monteserin MC, Soria B, Colorado M, Cladera A, Garcia-Guinon A, Calbacho M, Serrano A, Ortin X, Pedreno M, Amigo ML, Escoda L, Feliu E; PETHEMA Group, Spanish Society of Hematology. Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group. Leuk Res. 2016 Feb;41:12-20. doi: 10.1016/j.leukres.2015.11.012. Epub 2015 Dec 2.
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Ribera JM, Garcia-Calduch O, Ribera J, Montesinos P, Cano-Ferri I, Martinez P, Esteve J, Esteban D, Garcia-Fortes M, Alonso N, Gonzalez-Campos J, Bermudez A, Torrent A, Genesca E, Mercadal S, Martinez-Lopez J, Garcia-Sanz R. Ponatinib, chemotherapy, and transplant in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood Adv. 2022 Sep 27;6(18):5395-5402. doi: 10.1182/bloodadvances.2022007764.
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Saini N, Marin D, Ledesma C, Delgado R, Rondon G, Popat UR, Bashir Q, Hosing CM, Nieto Y, Alousi AM, Qazilbash MH, Ciurea S, Shpall E, Khouri I, Kantarjian H, Jabbour E, Ravandi F, Champlin RE, Kebriaei P. Impact of TKIs post-allogeneic hematopoietic cell transplantation in Philadelphia chromosome-positive ALL. Blood. 2020 Oct 8;136(15):1786-1789. doi: 10.1182/blood.2019004685.
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Arber DA, Orazi A, Hasserjian RP, Borowitz MJ, Calvo KR, Kvasnicka HM, Wang SA, Bagg A, Barbui T, Branford S, Bueso-Ramos CE, Cortes JE, Dal Cin P, DiNardo CD, Dombret H, Duncavage EJ, Ebert BL, Estey EH, Facchetti F, Foucar K, Gangat N, Gianelli U, Godley LA, Gokbuget N, Gotlib J, Hellstrom-Lindberg E, Hobbs GS, Hoffman R, Jabbour EJ, Kiladjian JJ, Larson RA, Le Beau MM, Loh ML, Lowenberg B, Macintyre E, Malcovati L, Mullighan CG, Niemeyer C, Odenike OM, Ogawa S, Orfao A, Papaemmanuil E, Passamonti F, Porkka K, Pui CH, Radich JP, Reiter A, Rozman M, Rudelius M, Savona MR, Schiffer CA, Schmitt-Graeff A, Shimamura A, Sierra J, Stock WA, Stone RM, Tallman MS, Thiele J, Tien HF, Tzankov A, Vannucchi AM, Vyas P, Wei AH, Weinberg OK, Wierzbowska A, Cazzola M, Dohner H, Tefferi A. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood. 2022 Sep 15;140(11):1200-1228. doi: 10.1182/blood.2022015850.
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Paul S, Short NJ. Central Nervous System Involvement in Adults with Acute Leukemia: Diagnosis, Prevention, and Management. Curr Oncol Rep. 2022 Apr;24(4):427-436. doi: 10.1007/s11912-022-01220-4. Epub 2022 Feb 10.
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Related Links
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Other Identifiers
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PETHEMA LALPh2022
Identifier Type: -
Identifier Source: org_study_id