A GIMEMA study to evaluate the safety and efficacy of the drug, called ponatinib, which is administrated at 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to another drug called imatinib

Phase 1

• Conditions: Chronic Myeloid Leukemia (CML) in Chronic Phase (CP); MedDRA version: 21.1Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-001102-34-IT
• Lead Sponsor: FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Cytogenetic and/or molecular confirmed diagnosis of Ph+ and/or BCR-ABL1+ CML
2.2.Age = 18 years and = 70 years old
3. Chronic phase CML
4. Prior treatment with Imatinib, any dose
5. Resistance to imatinib, as defined by any one of the ELN 2013 failure criteria, as follows:
¿ no complete hematologic response (CHR) at 3 months
¿ no cytogenetic response (CyR) (Ph+ > 95%) at 3 months
¿ Less than partial CyR (PCyR, Ph+ > 35%) at 6 months
¿ BCR-ABL1 > 10% at 6 months
¿ Non complete CyR (CCyR) (Ph+ > 0%) at 12 months
¿ BCR-ABL1 > 1% at 12 months
¿ Loss of CHR at any time
¿ Loss of CCyR at any time
¿ Confirmed loss of major molecular response (MMR) (BCR-ABL1 ¿ 0.1% in two
consecutive tests, of which one ¿ 1%) at any time
¿ Any new BCR-ABL1 mutation, at any time
6. For females of childbearing potential, a negative pregnancy test must be documented prior
to enrolment
7. An effective form of contraception with their sexual partners from enrolment through 4
months after the end of treatment
8. Signed written informed consent according to ICH/EU/GCP and national local laws prior
to any study procedures
9. Willingness and ability to comply with scheduled visits and study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Accelerated or blastic phase CML
2. Patients previously treated with nilotinib or dasatinib
3. Patients with the T315I mutation
4. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis or
of alcohol abuse
5. Patients with history of acute myocardial infarction (AMI), or unstable angina or
coronary heart disease (CHD), congestive heart failure, cerebrovascular events (CVE)
(stroke or transitory ischemic attack), or peripheral artery occlusive disease (PAOD)
6. Compelled to take medications that are known to be associated with Torsades de
Pointes and/or with significant QTc prolongation
7. Pregnant or breastfeeding;
8. Any condition or illness that, in the opinion of the Investigator, would compromise patient
safety or interfere with the evaluation of the drug
9. Lack of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified