Myeloproliferative Neoplasms Clinical Trial

Asciminib Roll-over Study

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

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Full 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 the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Participant with PH+ leukemia-cml/" >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.
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:

Participant has been discontinued from parent study treatment.
Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
Participant's ongoing treatment is currently approved and reimbursed at country level.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

Applicable only for participants on bosutinib treatment that switch to asciminib treatment at enrollment:

Asymptomatic pancreatitis
abnormal ECG
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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 4

Estimated Enrollment:

347

Study ID:

NCT04877522

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 52 Locations for this study

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Michigan Med University of Michigan .
Ann Arbor Michigan, 48109, United States More Info
Moshe Talpaz
Principal Investigator
Memorial Sloan Kettering
New York New York, 10017, United States More Info
Dalisa Espinosa
Contact
646-497-9068
[email protected]
Michael Mauro
Principal Investigator
Oregon Health Sciences University .
Portland Oregon, 97239, United States
Uni of TX MD Anderson Cancer Cntr
Houston Texas, 77030, United States More Info
Contact
713-792-2921
Koji Sasaki
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1221, Argentina
Novartis Investigative Site
Wien , 1140, Austria
Novartis Investigative Site
Rio de Janeiro RJ, 20211, Brazil
Novartis Investigative Site
Sao Paulo SP, 05403, Brazil
Novartis Investigative Site
Sao Paulo SP, 08270, Brazil
Novartis Investigative Site
Varna , 9000, Bulgaria
Novartis Investigative Site
Montreal Quebec, H1T 2, Canada
Novartis Investigative Site
Ostrava Poruba, 708 5, Czechia
Novartis Investigative Site
Brno-Bohunice , 639 0, Czechia
Novartis Investigative Site
Copenhagen , DK-21, Denmark
Novartis Investigative Site
Bordeaux , 33076, France
Novartis Investigative Site
Marseille , 13273, France
Novartis Investigative Site
Paris 10 , 75475, France
Novartis Investigative Site
Vandoeuvre les Nancy , 54511, France
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Frankfurt , 60590, Germany
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Jena , 07740, Germany
Novartis Investigative Site
Milano MI, 20162, Italy
Novartis Investigative Site
Roma RM, 00161, Italy
Novartis Investigative Site
Napoli , 80132, Italy
Novartis Investigative Site
Kobe-shi Hyogo, 650-0, Japan
Novartis Investigative Site
Uijeongbu si Gyeonggi Do, 11759, Korea, Republic of
Novartis Investigative Site
Busan , 49201, Korea, Republic of
Novartis Investigative Site
Jeollanam , 51976, Korea, Republic of
Novartis Investigative Site
Beirut , 1107 , Lebanon
Novartis Investigative Site
Monterrey Nuevo Leon, 64460, Mexico
Novartis Investigative Site
Krakow , 30-68, Poland
Novartis Investigative Site
Warszawa , 02 77, Poland
Novartis Investigative Site
Wroclaw , 50 36, Poland
Novartis Investigative Site
Lisboa , 1099 , Portugal
Novartis Investigative Site
Porto , 4200-, Portugal
Novartis Investigative Site
Timisoara , 30007, Romania
Novartis Investigative Site
Moscow , 12516, Russian Federation
Novartis Investigative Site
Moscow , 12528, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19734, Russian Federation
Novartis Investigative Site
St Petersburg , 19102, Russian Federation
Novartis Investigative Site
Riyadh , 11211, Saudi Arabia
Novartis Investigative Site
Singapore , 16960, Singapore
Novartis Investigative Site
Sevilla Andalucia, 41009, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Bilbao Pais Vasco, 48013, Spain
Novartis Investigative Site
Madrid , 28006, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Valencia , 46026, Spain
Novartis Investigative Site
Taoyuan , 33305, Taiwan
Novartis Investigative Site
Samsun , 55139, Turkey
Novartis Investigative Site
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 4

Estimated Enrollment:

347

Study ID:

NCT04877522

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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