2024-516048-24-00Not yet recruitingPhase 2
OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS
Centre Hospitalier De Versailles37 sites in 1 country40 target enrollmentStarted: July 25, 2024Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 37
- Primary Endpoint
- The primary endpoint is Overall Survival by 2 years
Study Overview
Brief Summary
The primary objective of this study is to determine the overall survival of patients with AP-CML (cohort A) and MBC-CML (cohort-B) treated with the combination of ponatinib and 5-azacitidine by 2 years.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged 18 years or more
- •Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile).
- •Have fully recovered (≤ grade 1, returned to baseline, or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
- •Patient affiliated to or beneficiary of the French National Health Service
- •Signed informed consent
- •Patient with Philadelphia chromosome positive CML in blast crisis: MBC-CML is defined by the presence of ≥ 20% blasts in the bone marrow and/or peripheral blood or the presence of extramedullary disease.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or
- •Have adequate renal function as defined by the following criterion: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for institution
- •Have adequate hepatic function as defined by the following criteria: a. Total serum bilirubin ≤ 1.5 × ULN, unless due to Gilbert’s syndrome or CML / b. Alanine aminotransferase (ALT) ≤ 2.5 × ULN, or ≤ 5 × ULN unless related to the disease / c. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN unless related to the disease
- •Have normal pancreatic status as defined by serum lipase and/or amylase ≤ 1.5 × ULN
- •Have normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.
- •Have a negative pregnancy test documented prior to enrolment (for females of childbearing potential).
Exclusion Criteria
- •Pregnant or lactating women
- •Intake of medications with a known risk of Torsades de Pointes
- •Have active central nervous system (CNS) disease as evidenced by cytology or pathology.
- •Have uncontrolled hypertension (diastolic blood pressure > 90 mmHg; systolic > 150 mmHg). Patients with hypertension should be under treatment on study entry to affect blood pressure control.
- •Have any condition or illness that, in the opinion of the investigator, would compromise patient’s safety or interfere with the evaluation of the drug
- •Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment
- •Prior history of hematopoietic stem cell transplantation
- •Cardiovascular disease: Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. / Myocardial infarction within the previous 6 months / Symptomatic cardiac arrhythmia requiring treatment
- •Individuals with another active malignancy
- •Patients at high risk or very high risk of arterio-veinous occlusive disease defined by European CVD score ( appendix 9)
- •Previously treated by 5-azacitidine or cytotoxic chemotherapy other than hydroxyurea
- •Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
- •Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
Outcomes
Primary Outcomes
The primary endpoint is Overall Survival by 2 years
The primary endpoint is Overall Survival by 2 years
Secondary Outcomes
- Adverse events - CTCAE Version 4.0
- Cumulative rate of patients achieving CHR
- Cumulative rate of patients achieving complete cytogenetic responses
- Cumulative rate of patients achieving molecular responses
- Cumulative rate of patients reverting to chronic phase CML
- Analysis of clonal architecture, methylation profile, bcr-abl mutations and cytogenetics in blast crisis and AP at baseline, and in case of relapse or failure
- Event free survival, duration of response
- Number of patients allocated to allogenic transplant
- Survival after transplant and post-transplantation relapse rate
Investigators
Project manager
Scientific
Centre Hospitalier De Versailles
Study Sites (37)
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