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Asciminib treatment optimization in ≥ 3rd line CML-CP
EU CTIS ID: 2024-511381-36-00
What this study is testing
To estimate the molecular response rate (MMR) of all the patients at week 48 with CML-CP following two or more prior TKI treatments and with no evidence of MMR at baseline.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
- Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib)
- Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Adequate end organ function (as per central laboratory tests)
You likely can't join if
- Known presence of the BCR-ABL1 T315I mutation at any time prior to study entry
- Known second chronic phase of CML after previous progression to AP/BC
- Previous treatment with a hematopoietic stem-cell transplantation
- Patient planning to undergo allogeneic hematopoietic stem cell transplantation
- Uncontrolled cardiac repolarization abnormality
- 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
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
- Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib)
- Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Adequate end organ function (as per central laboratory tests)
- Known presence of the BCR-ABL1 T315I mutation at any time prior to study entry
- Known second chronic phase of CML after previous progression to AP/BC
- Previous treatment with a hematopoietic stem-cell transplantation
- Patient planning to undergo allogeneic hematopoietic stem cell transplantation
- Uncontrolled cardiac repolarization abnormality
- 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
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
- History of ongoing active acute or chronic liver disease
The study team makes the final eligibility decision.
Where it's taking place
- Vietnam
- Oman
- United Kingdom
- Canada
- Argentina
- Brazil
- Korea, Republic of
- Malaysia
- Singapore
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vietnam; Oman; United Kingdom; Canada; Argentina; Brazil and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.