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NCT04877522PHASE4Recruiting

Asciminib Roll-over Study

Novartis Pharmaceuticals

Start Date

8/30/2022

Completion Date

8/30/2030

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 7 years to 100 years

Key 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. Key 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 Other protocol-defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Asciminib single agent

DRUG

Imatinib

DRUG

Nilotinib

DRUG

Bosutinib

DRUG

Dasatinib

DRUG

Asciminib single agent pediatric formulation

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Conditions

Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Locations

Michigan Med University of Michigan

Ann Arbor, Michigan 48109 5271

United States

Memorial Sloan Kettering

New York, New York 10017

United States

Oregon Health Sciences University

Portland, Oregon 97239

United States

Texas Oncology

Dallas, Texas 75251

United States

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas 77030

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Novartis Investigative Site

CABA, Buenos Aires C1221ADC

Argentina

Novartis Investigative Site

Capital Federal, C1114AAN

Argentina

Novartis Investigative Site

Graz, 8036

Austria

Novartis Investigative Site

Vienna, 1140

Austria

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro 20211-030

Brazil

Novartis Investigative Site

São Paulo, São Paulo 05403 000

Brazil

Novartis Investigative Site

São Paulo, São Paulo 08270-070

Brazil

Novartis Investigative Site

Varna, 9000

Bulgaria

Novartis Investigative Site

Montreal, Quebec H1T 2M4

Canada

Novartis Investigative Site

Chongqing, Chongqing Municipality 400010

China

Novartis Investigative Site

Guangzhou, Guangdong 510515

China

Novartis Investigative Site

Zhengzhou, Henan 450008

China

Novartis Investigative Site

Wuhan, Hubei 430022

China

Novartis Investigative Site

Changchun, Jilin 130021

China

Novartis Investigative Site

Xian, Shanxi 710004

China

Novartis Investigative Site

Chengdu, Sichuan 610041

China

Novartis Investigative Site

Beijing, 100044

China

Novartis Investigative Site

Beijing, 100730

China

Novartis Investigative Site

Shanghai, 200025

China

Novartis Investigative Site

Shenyang, 110004

China

Novartis Investigative Site

Tianjin, 300020

China

Novartis Investigative Site

Ostrava, Poruba 708 52

Czechia

Novartis Investigative Site

Brno, 625 00

Czechia

Novartis Investigative Site

Copenhagen, DK-2100

Denmark

Novartis Investigative Site

Bordeaux, 33076

France

Novartis Investigative Site

Lyon, 69373

France

Novartis Investigative Site

Marseille, 13273

France

Novartis Investigative Site

Nantes, 44093

France

Novartis Investigative Site

Paris, 75475

France

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511

France

Novartis Investigative Site

Frankfurt am Main, Hesse 60590

Germany

Novartis Investigative Site

Jena, Thuringia 07740

Germany

Novartis Investigative Site

Berlin, 13353

Germany

Novartis Investigative Site

Kiel, 24116

Germany

Novartis Investigative Site

Milan, MI 20162

Italy

Novartis Investigative Site

Roma, RM 00161

Italy

Novartis Investigative Site

Naples, 80131

Italy

Novartis Investigative Site

Kobe, Hyōgo 650-0017

Japan

Novartis Investigative Site

Beirut, 113-0236

Lebanon

Novartis Investigative Site

George Town, Pulau Pinang 10450

Malaysia

Novartis Investigative Site

Johor Bahru, 80100

Malaysia

Novartis Investigative Site

Kuala Selangor, 68000

Malaysia

Novartis Investigative Site

Monterrey, Nuevo León 64460

Mexico

Novartis Investigative Site

Khoudh, 123

Oman

Novartis Investigative Site

Katowice, 40-519

Poland

Novartis Investigative Site

Krakow, 30-688

Poland

Novartis Investigative Site

Warsaw, 00-791

Poland

Novartis Investigative Site

Wroclaw, 50 367

Poland

Novartis Investigative Site

Lisbon, 1099-023

Portugal

Novartis Investigative Site

Porto, 4200-072

Portugal

Novartis Investigative Site

Timișoara, 300079

Romania

Novartis Investigative Site

Moscow, 125167

Russia

Novartis Investigative Site

Moscow, 125284

Russia

Novartis Investigative Site

Saint Petersburg, 191024

Russia

Novartis Investigative Site

Saint Petersburg, 197341

Russia

Novartis Investigative Site

Riyadh, 11211

Saudi Arabia

Novartis Investigative Site

Singapore, 169608

Singapore

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do 11759

South Korea

Novartis Investigative Site

Busan, 49201

South Korea

Novartis Investigative Site

Jeollanam, 519763

South Korea

Novartis Investigative Site

Seoul, 03080

South Korea

Novartis Investigative Site

Santiago Compostela, A Coruna 15706

Spain

Novartis Investigative Site

Badalona, Barcelona 08916

Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona 08907

Spain

Novartis Investigative Site

Bilbao, Bizkaia 48013

Spain

Novartis Investigative Site

Santa Cruz, Santa Cruz De Tenerife 38009

Spain

Novartis Investigative Site

Barcelona, 08035

Spain

Novartis Investigative Site

Barcelona, 08036

Spain

Novartis Investigative Site

Madrid, 28006

Spain

Novartis Investigative Site

Madrid, 28034

Spain

Novartis Investigative Site

Madrid, 28041

Spain

Novartis Investigative Site

Seville, 41009

Spain

Novartis Investigative Site

Valencia, 46026

Spain

Novartis Investigative Site

Taoyuan, 33305

Taiwan

Novartis Investigative Site

Samsun, Atakum 55200

Turkey (Türkiye)

Novartis Investigative Site

London, W12 0HS

United Kingdom

Novartis Investigative Site

Oxford, OX3 7LE

United Kingdom

Novartis Investigative Site

Hanoi, 100000

Vietnam

Novartis Investigative Site

Ho Chi Minh City, 70000

Vietnam