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

NCT06409936 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • CML, Chronic Phase
  • Chronic Myeloid Leukemia, Chronic Phase
  • Chronic Myeloid Leukemia, BCR/ABL-Positive
  • Chronic Myeloid Leukemia

Interventions

DRUG

Asciminib

both arms will include asciminib treatment

DRUG

Nilotinib

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

Sponsors & Collaborators

  • Grupo Español de Leucemia Mieloide Crónica

    collaborator UNKNOWN

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Fausto Castagnetti · "Seragnoli" Institute of Hematology Bologna (Italy)

  • Valentin Garcia Gutierrez · Hematology Unit, Hospital Universitario Ramón y Cajal, Madrid (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2029-06-30
Completion
2032-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409936 on ClinicalTrials.gov