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.

Who is this study for? Patients with chronic myelogenous leukemia in chronic phase previously treated with 2 or more tyrosine kinase inhibitors
What treatments are being studied? ABL001
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations. In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: No
View:

• Male or female patients with a diagnosis of CML-CP ≥ 18 years of age

• Patients must meet all the following laboratory values at the screening visit:

• < 15% blasts in peripheral blood and bone marrow

• < 30% blasts plus promyelocytes in peripheral blood and bone marrow

• < 20% basophils in the peripheral blood

• ≥ 50 x 109/L (≥ 50,000/mm3) platelets

• Transient prior therapy related thrombocytopenia (< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable

• No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly Prior treatment with a minimum of 2 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

• Warning is defined as:

• Three months after the initiation of treatment: BCR-ABL1 > 10% IS

• Six months after the initiation of treatment: BCR-ABL1 >1-10% IS

• Twelve months after the initiation of treatment BCR-ABL1>0,1-1% IS

• At any time after the initiation of therapy BCR-ABL1 >0.1-1% IS, loss of MMR (>0.1% with 5-fold increase of BCR-ABL1 transcripts).

• In addition, patients with failure of treatment according to the ELN 2020 recommendations will be eligible:

• Three months after the initiation of treatment: BCR-ABL1 > 10% IS if confirmed within 1-3 months

• Six months after the initiation of treatment: BCR-ABL1 >10% IS

• Twelve months after the initiation of treatment BCR-ABL1 >1% IS

• At any time after the initiation of therapy BCR-ABL1 >1% IS, emergence of resistance mutations, high-risk ACA

• Intolerance is defined as:

• Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)

• Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count [ANC] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer

Locations
Other Locations
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires
Novartis Investigative Site
Recruiting
Caba
Austria
Novartis Investigative Site
Recruiting
Graz
Novartis Investigative Site
Recruiting
Linz
Novartis Investigative Site
Recruiting
Wien
Canada
Novartis Investigative Site
Recruiting
Quebec
Novartis Investigative Site
Recruiting
Toronto
Novartis Investigative Site
Recruiting
Vancouver
France
Novartis Investigative Site
Recruiting
Bordeaux
Novartis Investigative Site
Recruiting
Lyon Cedex
Novartis Investigative Site
Recruiting
Montpellier Cedex 5
Novartis Investigative Site
Recruiting
Nantes Cedex 1
Novartis Investigative Site
Recruiting
Paris Cedex 10
Germany
Novartis Investigative Site
Recruiting
Berlin
Novartis Investigative Site
Recruiting
Frankfurt
Novartis Investigative Site
Recruiting
Jena
Novartis Investigative Site
Recruiting
Kiel
Novartis Investigative Site
Recruiting
Mannheim
Novartis Investigative Site
Recruiting
Muenchen
Greece
Novartis Investigative Site
Recruiting
Athens
Novartis Investigative Site
Recruiting
Thessaloniki
Italy
Novartis Investigative Site
Recruiting
Monza
Novartis Investigative Site
Recruiting
Roma
Novartis Investigative Site
Recruiting
Roma
Novartis Investigative Site
Recruiting
Verona
Malaysia
Novartis Investigative Site
Recruiting
Johor Bahru
Novartis Investigative Site
Recruiting
Kota Kinabalu
Novartis Investigative Site
Recruiting
Penang
Novartis Investigative Site
Recruiting
Selangor
Oman
Novartis Investigative Site
Recruiting
Muscat
Poland
Novartis Investigative Site
Recruiting
Katowice
Novartis Investigative Site
Recruiting
Krakow
Novartis Investigative Site
Recruiting
Warszawa
Republic of Korea
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Taegu
Russian Federation
Novartis Investigative Site
Withdrawn
Moscow
Singapore
Novartis Investigative Site
Recruiting
Singapore
Novartis Investigative Site
Recruiting
Singapore
Novartis Investigative Site
Recruiting
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona
Novartis Investigative Site
Recruiting
Bilbao
Novartis Investigative Site
Recruiting
Madrid
Novartis Investigative Site
Recruiting
Santa Cruz De Tenerife
Novartis Investigative Site
Recruiting
Santiago De Compostela
United Kingdom
Novartis Investigative Site
Recruiting
Cambridge
Novartis Investigative Site
Recruiting
Leeds
Novartis Investigative Site
Recruiting
London
Novartis Investigative Site
Recruiting
London
Viet Nam
Novartis Investigative Site
Recruiting
Hanoi
Novartis Investigative Site
Recruiting
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
Time Frame
Start Date: October 13, 2021
Estimated Completion Date: June 11, 2026
Participants
Target number of participants: 195
Treatments
Experimental: ABL001
Participants will be treated with 80 mg of ABL001 (40 mg BID or 80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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