Actively Recruiting
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2025-07-08
160
Participants Needed
11
Research Sites
361 weeks
Total Duration
On this page
Sponsors
G
Gruppo Italiano Malattie EMatologiche dell'Adulto
Lead Sponsor
G
Grupo Español de Leucemia Mieloide Crónica
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ chronic myeloid leukemia
- Age 18 years or older
- Early chronic phase, less than 3 months from diagnosis
- Presence of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 for international scale reporting
- Prior treatment with any tyrosine kinase inhibitor (TKI) for 30 days or less; prior hydroxyurea or anagrelide allowed
- ECOG performance status of 0, 1, or 2
- Adequate organ function including bilirubin, liver enzymes, amylase, lipase, alkaline phosphatase, and creatinine clearance above set limits
- Signed informed consent per regulations
- Use of effective contraception during the study and for 30 days after treatment ends
You will not qualify if you...
- Chronic myeloid leukemia in blast phase or second chronic phase after blast phase
- Prior treatment with TKIs for more than 30 days
- Refusal or inability to provide informed consent
- Significant cardiac disease posing safety risk, including recent myocardial infarction, uncontrolled heart failure, unstable angina, or serious arrhythmias without pacemaker
- Severe or uncontrolled medical conditions that increase safety risks or affect study compliance
- History of acute pancreatitis within 1 year or chronic pancreatitis
- History of acute or chronic liver disease
- Active malignancy within 2 years prior to study except treated basal cell skin cancer or carcinoma in situ
- Known infection with HIV, Hepatitis B, or Hepatitis C
- Gastrointestinal conditions impairing drug absorption
- Pregnant or lactating women
- Women of child-bearing potential not using highly effective contraception during dosing and 30 days after treatment ends
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Hospital del Mar (Barcelona)
Barcelona, Spain
Actively Recruiting
2
Hospital Universitario Basurto
Bilbao, Spain
Actively Recruiting
3
Institut Català d'Oncologia Girona
Girona, Spain
Actively Recruiting
4
Hospital Virgen de las Nieves
Granada, Spain
Actively Recruiting
5
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
Actively Recruiting
6
Hospital Gral U. Gregorio Marañón
Madrid, Spain
Actively Recruiting
7
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
8
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
9
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
10
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
11
Hospital Universitario La Fe Valencia
Valencia, Spain
Actively Recruiting
Research Team
P
Paola Fazi
CONTACT
E
Enrico Crea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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