Potential of asciminib in early chronic‑phase CML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PEARL is a randomized, open‑label phase 2 study in adults with newly diagnosed chronic‑phase BCR‑ABL–positive CML comparing asciminib single‑agent (80 mg once daily) versus asciminib plus nilotinib (asciminib 40 mg twice daily plus nilotinib 300 mg twice daily after an initial period). Patients receive at least two years of treatment (core phase), followed by a two‑year consolidation phase with continued asciminib and reduced nilotinib dosing in the combination arm. Patients who maintain a stable deep molecular response (MR4) through year four may stop therapy and enter a treatment‑free remission (TFR) phase, with the proportion maintaining TFR assessed at five years. Disease is monitored by quantitative PCR throughout the study to guide dose adjustments and discontinuation decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML
* Age ≥ 18 years
* Early chronic phase, less than 3 months from diagnosis
* Evidence at the time of study entry of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 (b2a2 or b3a2), which are required for BCR::ABL1 international scale reporting
* Prior treatment with any TKI for 30 days or less; prior treatment with hydroxyurea or anagrelide is allowed
* ECOG performance status of 0, 1 or 2
* Adequate end organ function as defined by Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3.0 x ULN Alanine transaminase (ALT) ≤ 3.0 x ULN Serum amylase ≤ ULN Serum lipase ≤ ULN Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related Creatinine clearance \> 50 ml/min using Cockcroft-Gault formula
* Signed written informed consent according to ICH/EU/GCP and national local laws prior to any study procedure
* An effective form of contraception with their sexual partners from enrolment through 30 days after the end of treatment

Exclusion Criteria:

* CML in blast phase (BP) or in second chronic phase after previous BP, according to WHO criteria
* Previous treatment with TKIs for more than 30 days
* Refusal or impossibility to give an informed consent
* History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months), uncontrolled congestive heart failure, unstable angina (within last 6 months), clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection)
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
* History of acute or chronic liver disease
* History of other active malignancy within 2 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab / anti HBc) will be performed at study entry
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
* Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 30 days after the end of treatment

Where it's running

• Hospital del Mar (Barcelona)
  Barcelona, Spain Recruiting
• Hospital Universitario Basurto
  Bilbao, Spain Recruiting
• Institut Català d'Oncologia Girona
  Girona, Spain Recruiting
• Hospital Virgen de las Nieves
  Granada, Spain Recruiting
• Hospital Universitario de Gran Canaria Dr. Negrín
  Las Palmas de Gran Canaria, Spain Recruiting
• Hospital Gral U. Gregorio Marañón
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Fausto Castagnetti — "Seragnoli" Institute of Hematology Bologna (Italy)
• Study coordinator: Paola Fazi
• Email: p.fazi@gimema.it
• Phone: 0670390528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.