MedDataX Logo

Asciminib Roll-over Study

NCT ID: NCT04877522

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2030-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

NCT05384587

Chronic Myelogenous Leukemia - Chronic Phase
ACTIVE_NOT_RECRUITING PHASE2

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

NCT03578367

CML Chronic Myelogenous Leukemia Leukemia, Myeloid Chronic +1 more
COMPLETED PHASE2

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

NCT05456191

Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
ACTIVE_NOT_RECRUITING PHASE3

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

NCT04971226

Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
ACTIVE_NOT_RECRUITING PHASE3

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

NCT04925479

Myeloid Leukemia, Philadelphia Positive
RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Myelogenous Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asciminib single agent group

Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib

Group Type EXPERIMENTAL

Asciminib single agent

Intervention Type DRUG

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Bosutinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib

Group Type OTHER

Bosutinib

Intervention Type DRUG

Taken orally, once daily, with food

Bosutinib-Asciminib switch group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

Group Type EXPERIMENTAL

Asciminib single agent

Intervention Type DRUG

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Asciminib in combination with imatinib group

Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

Taken orally, once daily, in the morning with low-fat meal

Asciminib in combination with nilotinib group

Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Taken orally, twice daily, on an empty stomach

Imatinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib

Group Type OTHER

Imatinib

Intervention Type DRUG

Taken orally, once daily, in the morning with low-fat meal

Nilotinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib

Group Type OTHER

Nilotinib

Intervention Type DRUG

Taken orally, twice daily, on an empty stomach

Asciminib in combination with dasatinib group

Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Dasatinib single agent group

Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.

Group Type OTHER

Dasatinib

Intervention Type DRUG

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Dasatinib-Asciminib switch group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study

Group Type EXPERIMENTAL

Asciminib single agent

Intervention Type DRUG

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Asciminib single agent formulation for Pediatric

Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib

Group Type EXPERIMENTAL

Asciminib single agent pediatric formulation

Intervention Type DRUG

Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Intervention Type DRUG

Imatinib

Taken orally, once daily, in the morning with low-fat meal

Intervention Type DRUG

Nilotinib

Taken orally, twice daily, on an empty stomach

Intervention Type DRUG

Bosutinib

Taken orally, once daily, with food

Intervention Type DRUG

Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Intervention Type DRUG

Asciminib single agent pediatric formulation

Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABL001 STI571 AMN107 Sprycel ABL001

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.

Exclusion Criteria

1. Participant has been discontinued from parent study treatment.
2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
3. Participant's ongoing treatment is currently approved and reimbursed at country level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:

* Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
* QTcF\>480msec or inability to determine QTc interval
* any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
Minimum Eligible Age

7 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michigan Med University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Memorial Sloan Kettering

New York, New York, United States

Site Status RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status ACTIVE_NOT_RECRUITING

Texas Oncology

Dallas, Texas, United States

Site Status RECRUITING

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

Site Status RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status RECRUITING

Novartis Investigative Site

Capital Federal, , Argentina

Site Status RECRUITING

Novartis Investigative Site

Graz, , Austria

Site Status RECRUITING

Novartis Investigative Site

Vienna, , Austria

Site Status RECRUITING

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Novartis Investigative Site

Varna, , Bulgaria

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status RECRUITING

Novartis Investigative Site

Zhengzhou, Henan, China

Site Status RECRUITING

Novartis Investigative Site

Wuhan, Hubei, China

Site Status RECRUITING

Novartis Investigative Site

Changchun, Jilin, China

Site Status RECRUITING

Novartis Investigative Site

Xian, Shanxi, China

Site Status RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status COMPLETED

Novartis Investigative Site

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shenyang, , China

Site Status RECRUITING

Novartis Investigative Site

Tianjin, , China

Site Status RECRUITING

Novartis Investigative Site

Ostrava, Poruba, Czechia

Site Status RECRUITING

Novartis Investigative Site

Brno, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Copenhagen, , Denmark

Site Status COMPLETED

Novartis Investigative Site

Bordeaux, , France

Site Status RECRUITING

Novartis Investigative Site

Lyon, , France

Site Status RECRUITING

Novartis Investigative Site

Marseille, , France

Site Status RECRUITING

Novartis Investigative Site

Nantes, , France

Site Status RECRUITING

Novartis Investigative Site

Paris, , France

Site Status RECRUITING

Novartis Investigative Site

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Kiel, , Germany

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Roma, RM, Italy

Site Status RECRUITING

Novartis Investigative Site

Napoli, , Italy

Site Status COMPLETED

Novartis Investigative Site

Kobe, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beirut, , Lebanon

Site Status COMPLETED

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Site Status RECRUITING

Novartis Investigative Site

Johor Bahru, , Malaysia

Site Status RECRUITING

Novartis Investigative Site

Kuala Selangor, , Malaysia

Site Status RECRUITING

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Novartis Investigative Site

Khoudh, , Oman

Site Status RECRUITING

Novartis Investigative Site

Katowice, , Poland

Site Status RECRUITING

Novartis Investigative Site

Krakow, , Poland

Site Status COMPLETED

Novartis Investigative Site

Warsaw, , Poland

Site Status RECRUITING

Novartis Investigative Site

Wroclaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Lisbon, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Porto, , Portugal

Site Status RECRUITING

Novartis Investigative Site

Timișoara, , Romania

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Riyadh, , Saudi Arabia

Site Status COMPLETED

Novartis Investigative Site

Singapore, , Singapore

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Busan, , South Korea

Site Status COMPLETED

Novartis Investigative Site

Jeollanam, , South Korea

Site Status COMPLETED

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Site Status RECRUITING

Novartis Investigative Site

Badalona, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

Bilbao, Bizkaia, Spain

Site Status RECRUITING

Novartis Investigative Site

Santa Cruz, Santa Cruz De Tenerife, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Seville, , Spain

Site Status RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status RECRUITING

Novartis Investigative Site

Taoyuan District, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Samsun, Atakum, Turkey (Türkiye)

Site Status RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Novartis Investigative Site

Oxford, , United Kingdom

Site Status RECRUITING

Novartis Investigative Site

Hanoi, , Vietnam

Site Status RECRUITING

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Austria Brazil Bulgaria Canada China Czechia Denmark France Germany Italy Japan Lebanon Malaysia Mexico Oman Poland Portugal Romania Russia Saudi Arabia Singapore South Korea Spain Taiwan Turkey (Türkiye) United Kingdom Vietnam

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

[email protected]
1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kelly Whitley

Role: primary

[email protected]

Shakira Pascual

Role: primary

[email protected]
646-497-9068

Jessica Maner

Role: primary

[email protected]
+1 214 370 1000

Susan Aline Wahl

Role: primary

[email protected]
+1 713 792 2921

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-000602-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507557-16-00

Identifier Type: OTHER

Identifier Source: secondary_id

CABL001A2001B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
NCT02081378 COMPLETED PHASE1
Frontline Asciminib Combination in Chronic Phase CML
NCT03906292 ACTIVE_NOT_RECRUITING PHASE2
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
NCT06236724 RECRUITING PHASE2
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
NCT06514534 RECRUITING PHASE2
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
NCT07250087 RECRUITING PHASE1
Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
NCT05201066 ACTIVE_NOT_RECRUITING PHASE2
Asciminib RMP Study
NCT05943522 RECRUITING
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT06308588 RECRUITING PHASE1/PHASE2
Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT07040982 NOT_YET_RECRUITING PHASE1
Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
NCT06773936 ENROLLING_BY_INVITATION PHASE2
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
NCT06051409 RECRUITING PHASE3
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
NCT04948333 ACTIVE_NOT_RECRUITING PHASE3
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
NCT06629584 RECRUITING PHASE2
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
NCT06409936 RECRUITING PHASE2
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
NCT03106779 COMPLETED PHASE3
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT03516617 RECRUITING PHASE2
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
NCT01034410 TERMINATED PHASE2
Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors
NCT04795427 COMPLETED PHASE2
A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL
NCT04722172 ACTIVE_NOT_RECRUITING PHASE2
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
NCT01279473 COMPLETED PHASE1/PHASE2
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT06124157 RECRUITING PHASE3
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
NCT06714591 RECRUITING PHASE1
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT04169737 RECRUITING PHASE2
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
NCT04666259 COMPLETED PHASE3
Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML
NCT04913922 RECRUITING PHASE2