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New treatment option for CML, Chronic Phase
Official title PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
ClinicalTrials.gov ID: NCT06409936
What this study is testing
What is Asciminib?
Asciminib is an investigational medicine, given as an once-daily, being studied as a potential treatment for cml, chronic phase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Prior treatment with any TKI for 30 days or less; prior treatment with hydroxyurea or anagrelide is allowed
You likely can't join if
- 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...
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise...
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Bilbao, Spain
- Girona, Spain
- Granada, Spain
- Las Palmas de Gran Canaria, Spain
- Madrid, Spain
- Murcia, Spain
- Salamanca, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Bilbao, Spain; Girona, Spain; Granada, Spain; Las Palmas de Gran Canaria, Spain; Madrid, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.