RecruitingPhase 2NCT06409936

PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML


Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrollment

160 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B). All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued. During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily. The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The PEARL study tests asciminib — a newer type of targeted drug — in patients recently diagnosed with chronic myeloid leukemia (CML, a blood cancer). Asciminib works differently from older CML drugs, and this study looks at whether using it early leads to better long-term remission. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Philadelphia chromosome-positive CML in chronic phase within the past 3 months - You have had little to no prior treatment (30 days or fewer of TKI therapy; hydroxyurea or anagrelide is allowed) - Your organ function is adequate **You may NOT be eligible if...** - You have had more than 30 days of TKI therapy - Your CML is in an accelerated or blast phase - You have serious heart conditions (e.g., recent heart attack, certain rhythm problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsciminib

both arms will include asciminib treatment

DRUGNilotinib

in the arm B the nilotinib will be added on in all patients


Locations(11)

Hospital del Mar (Barcelona)

Barcelona, Spain

Hospital Universitario Basurto

Bilbao, Spain

Institut Català d'Oncologia Girona

Girona, Spain

Hospital Virgen de las Nieves

Granada, Spain

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Spain

Hospital Gral U. Gregorio Marañón

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Universitario La Fe Valencia

Valencia, Spain

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NCT06409936


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