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Not yet taking people in ItalyPhase 1/2

Asciminib with chemotherapy, then blinatumomab, for children and young adults with relapsed leukemia

Tests asciminib in young people whose acute lymphoblastic leukemia returned or resisted treatment.

Key facts

Who runs it
Novartis Pharma AG
Where
Genoa, Monza, and Rome, ItalySee the 3 sitesAlso in 6 other countries, 22 sites
Trial code
Registry title
Study of the safety and efficacy of asciminib in pediatric and young adult participants with r/r Ph+ or ABL-class Ph-like ALL
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
22 people, planned
Started
30 Oct 2026
Expected to end
18 Jun 2036
Type of study
Interventional
Record updated
6 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children, teenagers and young adults with Ph+ or ABL-class Ph-like B-cell acute lymphoblastic leukemia (ALL) that has come back or did not respond to earlier treatment.

Age
From 1 year to 30 years at screening.
Sex
Both males and females can join.
Disease stage
Active B-cell ALL that has relapsed after at least one line of therapy, or that did not respond (primary refractory). Bone marrow must show more than 0.01% ALL cells. CNS1, CNS2, CNS3a or CNS3b is allowed.
Earlier treatment
At least one line of therapy for relapsed disease, or induction and 1 consolidation cycle for refractory disease. If anti-CD19 therapy was given (for example CD19 CAR T cells or blinatumomab), CD19 must still be seen on the leukemia cells afterwards. No stem cell transplant in the prior 12 weeks.
Biomarker or test result
Documented Ph+ ALL, or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements, found by local genetic testing. CD19 on the leukemia cells must be documented. People with a T315I mutation can join a separate cohort.

Main reasons for not taking part

  • More than 3 relapses of ALL
  • Disease outside the bone marrow (non-CNS and/or isolated CNS disease)
  • CNS3c, with clinical signs of CNS leukemia such as facial nerve palsy
  • Stem cell transplant in the prior 12 weeks
  • Active graft-versus-host disease, or any drug to treat or prevent it within 4 weeks

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 known T315I mutations are eligible for inclusion in a separate cohort)
  • 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 induction and 1 consolidation cycle) 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

Who cannot take part

  • 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
  • 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)
  • Participants with >3 relapses of ALL at screening

Where in Italy

Also in 6 other countries, 22 sites

  • IRCCS Istituto Giannina GasliniGenoa, ItalyNot yet recruiting
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNot yet recruiting
  • Ospedale Pediatrico Bambino GesùRome, ItalyNot yet recruiting

About the trial

What the trial wants to find out

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 and severity of AEs and laboratory safety findings during cycle 1. 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
Plain-language title
Asciminib with chemotherapy, then blinatumomab, for children and young adults with relapsed leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
6 October 2026