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Study of the safety and efficacy of asciminib in pediatric and young adult participants with r/r Ph+ or ABL-class Ph-like ALL
EU CTIS ID: 2025-522019-40-00
What this study is testing
The primary objective for Part 1 dose escalation is to determine the RP2D and the primary endpoints will be the incidence of DLTs and incidence of severity of AEs and laboratory safety findings. The primary objective for Part 2 dose expansion will be to assess complete remission rates at the end of cycle 1 and the primary endpoint will be proportion of CR evaluable Ph+ participants achieving CR at the end of cycle 1
- Phase I and Phase II (Integrated)- Other
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
- Male or female participants ≥1 year to ≤30 years of age at screening
- Participants with documented history of either Ph+ ALL or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements. Genetic testing will be performed locally and eligible alterations confirmed by treating investigators; central confirmation will not be performed as part of the study. (Of note, participants with T315I mutations are eligible for inclusion in Part 1 and Part 2).
- Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts >0.01% in participants with either: a. Primary refractory disease (>0.01% ALL blasts present at the end of consolidation) OR b. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR>0.01%) after at least one line of therapy
- Participants with CNS1, CNS2, CNS3a or CNS3b at screening.
- Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry) a. For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1.
You likely can't join if
- Participants with >3 relapses of ALL at screening.
- Extramedullary disease (non-CNS and/ or isolated CNS disease) at screening
- Participants with CNS3c at screening (Clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome).
- History of hematopoietic stem cell transplant within the prior 12 weeks
- Presence of active acute or chronic graft-versus-host disease (GVHD). Hematopoietic stem cell transplant recipients receiving any agent to treat or prevent GVHD within 4 weeks are not eligible for this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- United States
- Australia
- Taiwan
- United Kingdom
- Korea, Republic of
- Canada
- Malaysia
- Israel
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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; United States; Australia; Taiwan; United Kingdom; Korea, Republic of 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.