Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) MedDRA version: 21.1 Level: PT Classification code 10009013 Term: Chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10009013 Term: Chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ICLUSIG - 15 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE HDPE - 30 COMPRESSE
Product Name: ICLUSIG 15 MG
Product Code: [AP24534]
Pharmaceutical Form: Film-coated tablet
INN or
Sponsors
Associazione Italiana Pazienti Leucemia Mieloide Cronica (AIPLMC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures. 2) CML diagnosis, Chronic Phase (CP), treated with imatinib and bosutinib or bosutinib only. Previous treatment with dasatinib or nilotinib will not be allowed. 3) Resistant or intolerant to imatinib and/or bosutinib. 4) Able to take oral therapy. 5) Female or male, 18 years of age or older. 6) ECOG performance status 0-2. 7) Minimum life expectancy of 3 months or more. 8) Adequate organ function as defined by the following criteria: - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN) or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy - Total serum bilirubin = 1.5 x ULN (except patients with documented Gilbert’s syndrome) - Creatinine = 1.5 x ULN - Prothrombin time (PT) =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Current treatment on another therapeutic clinical trial. 2) Received TKI therapy within 7 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by NCI CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered. 3) Underwent autologous or allogeneic stem cell transplant 450 mg/dL). 12) Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib. 13) Have been diagnosed with another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate cancer, which are allowed within 3 years). 14) Pregnancy or breastfeeding 15) Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib 16) Have ongoing or active infection (including known history of human immunodeficiency virus [HIV] or hepatitis C virus [HCV]). Testing for these viruses is not required in the absence of history 17) Be positive for blood serum for Hepatitis B serology (Hepatitis B surface Antigen, Hepatitis B core Antibody, and Hepatitis B surface Antibody) at the time of screening 18) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration 19) Known hypersensitivity to one of IMP’s excipients, which is lactose monohydrate (rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess Ponatinib safety cardiovascular profile at 1 year after the study treatment initiation of each patient;Secondary Objective: 1. To assess the ponatinib safety profile at 2 and 3 years after the study treatment initiation. 2. To assess ponatinib venous occlusive safety profile at 1, 2 and 3 years after the study treatment initiation. 3. To assess the achievement of Complete Cytogenetic Response (CCyR) and/or BCR-ABL level <1% in resistant patients at 1, 2 and 3 years after the study treatment initiation. 4. To assess the achievement of Molecular responses (MMR [BCR-ABL level <0.1%] or better) at 1, 2 and 3 years after the study treatment initiation. 5. To assess the maintenance of response at 1, 2 and 3 years after the study treatment initiation in intolerant patients. 6. To assess the Overall Survival (OS), the Progression Free Survival (PFS) at 1, 2 and 3 years after the study treatment initiation in intolerant patients.;Primary end point(s): Exposure adjusted Rate of Arterial Occlusive Events (AOE) and Serious AOE (SOE) at 1 year after study treatment initiation of each patient;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exposure adjusted Rate of Venous Occlusive Events at 1, 2 and 3 years;Timepoint(s) of evaluation of this end point: 2 and 3 years; 1, 2 and 3 years | — |
Countries
Italy
Contacts
Public ContactGestione studi clinici
GalSeq srl
Outcome results
None listed