Asciminib treatment optimization in = 3rd line CML-CP

A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006057-21-AT

Enrollment

186

Registered

2021-07-26

Start date

2021-09-29

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia in chronic phase (CML-CP) MedDRA version: 21.0 Level: LLT Classification code 10009012 Term: Chronic myelogenous leukemia System Organ Class: 100000004864

Interventions

Product Name: Asciminib Product Code: ABL001 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ASCIMINIB Current Sponsor code: ABL001 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 Adequate end organ function (as per central laboratory tests) Other protocol defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: Known presence of the BCR-ABL1 T315I mutation at any time prior to study entry Known history of 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 Participation in a prior investigational study within 30 days prior to randomization or within 5-half-lives of the investigational product, whichever is longer. Other protocol defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is 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.;Secondary Objective: To evaluate the safety and tolerability of asciminib in patients with CML-CP following two or more prior TKI treatments. To assess the rate of MMR in patients without MMR at baseline and at alternative time points at weeks 12, 24, 36, 72, 96 and 144 To assess the rate of MMR at week 48 for patients with MMR at baseline To assess the time to MMR To assess the rate of early responses of BCR-ABL1 =10% and =1% at weeks 12, 24, 36 and 48 To assess the rate of deep molecular responses (MR4 and MR4.5) at weeks 12, 24, 36, 48, 72, 96 and 144 To assess cytogenetic response (% Ph+ metaphases) at weeks 48 and EOT. To characterize the impact of additional cytogenetic abnormalities on efficacy To assess cumulative molecular responses by all-time points To assess duration of MMR To assess sustained deep molecular responses as prerequisite for Treatment Free Remission (TFR) To assess rate of progressions (PFS) (Please refer to the protocol Table 2-1 for the full list);Primary end point(s): Major Molecular Response (MMR) rate at week 48.;Timepoint(s) of evaluation of this end point: Week 48	—

Measure

Time frame

Main Objective: The primary objective of the study is 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.;Secondary Objective: To evaluate the safety and tolerability of asciminib in patients with CML-CP following two or more prior TKI treatments. To assess the rate of MMR in patients without MMR at baseline and at alternative time points at weeks 12, 24, 36, 72, 96 and 144 To assess the rate of MMR at week 48 for patients with MMR at baseline To assess the time to MMR To assess the rate of early responses of BCR-ABL1 =10% and =1% at weeks 12, 24, 36 and 48 To assess the rate of deep molecular responses (MR4 and MR4.5) at weeks 12, 24, 36, 48, 72, 96 and 144 To assess cytogenetic response (% Ph+ metaphases) at weeks 48 and EOT. To characterize the impact of additional cytogenetic abnormalities on efficacy To assess cumulative molecular responses by all-time points To assess duration of MMR To assess sustained deep molecular responses as prerequisite for Treatment Free Remission (TFR) To assess rate of progressions (PFS) (Please refer to the protocol Table 2-1 for the full list);Primary end point(s): Major Molecular Response (MMR) rate at week 48.;Timepoint(s) of evaluation of this end point: Week 48

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Secondary

Measure	Time frame
Secondary end point(s): MMR rate at weeks 12, 24, 36, 72, 96 and 144. MMR rate at week 48 for patients with MMR at baseline. Time from the date of randomization to the date of first documented MMR Rate of BCR-ABL1 = 10% and =1% at weeks 12, 24, 36 and 48 Rate of MR4 and MR4.5 at weeks 12, 24, 36, 48, 72, 96 and 144. Rate of complete cytogenetic response (CCyR) at weeks 48 and EOT. Additional chromosomal abnormalities and occurrence of high-risk additional chromosomal abnormalities (ACAs) Rate of BCR-ABL1 = 10%, BCR-ABL1 =1%, MMR, MR4 and MR4.5 by all-time points. Duration of MMR. Duration of MR4 without loss of MMR. Time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause. Time from randomization to death. Time from randomization to treatment failure define as BCR-ABL1 > 1%. Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument.;Timepoint(s) of evaluation of this end point: Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144/EOT.	—

Measure

Time frame

Secondary end point(s): MMR rate at weeks 12, 24, 36, 72, 96 and 144. MMR rate at week 48 for patients with MMR at baseline. Time from the date of randomization to the date of first documented MMR Rate of BCR-ABL1 = 10% and =1% at weeks 12, 24, 36 and 48 Rate of MR4 and MR4.5 at weeks 12, 24, 36, 48, 72, 96 and 144. Rate of complete cytogenetic response (CCyR) at weeks 48 and EOT. Additional chromosomal abnormalities and occurrence of high-risk additional chromosomal abnormalities (ACAs) Rate of BCR-ABL1 = 10%, BCR-ABL1 =1%, MMR, MR4 and MR4.5 by all-time points. Duration of MMR. Duration of MR4 without loss of MMR. Time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause. Time from randomization to death. Time from randomization to treatment failure define as BCR-ABL1 > 1%. Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument.;Timepoint(s) of evaluation of this end point: Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144/EOT.

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Countries

Argentina, Austria, Brazil, Canada, France, Germany, Greece, Italy, Korea, Republic of, Malaysia, Oman, Poland, Russian Federation, Singapore, Spain, United Kingdom, Viet Nam

Contacts

Public ContactDrug Regulatory Affairs

Novartis Pharma GmbH

austria.dra@novartis.com+43 1 86657 0

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026