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Asciminib Roll-over Study

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Asciminib single agent
Asciminib
Imatinib
Nilotinib
Bosutinib
Dasatinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Chronic Myelogenous Leukemia, CML, ALL, CML-AP, CML-BP, CML-CP, myeloproliferative neoplasm, chronic phase, accelerated phase, blast phase, ABL001, asciminib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Michigan Med University of Michigan .Recruiting
  • Memorial Sloan KetteringRecruiting
  • Oregon Health Sciences University .Recruiting
  • Uni of TX MD Anderson Cancer CntrRecruiting
  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Other

Experimental

Experimental

Experimental

Other

Other

Experimental

Arm Label

Asciminib single agent group

Bosutinib single agent group

Bosutinib-asciminib switch group

Asciminib in combination with imatinib group

Asciminib in combination with nilotinib group

Imatinib single agent group

Nilotinib single agent group

Asciminib in combination with dasatinib group

Arm Description

Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib

Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib

Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib

Outcomes

Primary Outcome Measures

Number of participabts with adverse events (AEs) and serious adverse events (SAEs)
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.

Secondary Outcome Measures

Percentage of participants with clinical benefit as assessed by Investigator
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.

Full Information

First Posted
May 4, 2021
Last Updated
October 9, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04877522
Brief Title
Asciminib Roll-over Study
Official Title
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
August 27, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Keywords
Chronic Myelogenous Leukemia, CML, ALL, CML-AP, CML-BP, CML-CP, myeloproliferative neoplasm, chronic phase, accelerated phase, blast phase, ABL001, asciminib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
347 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asciminib single agent group
Arm Type
Experimental
Arm Description
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib
Arm Title
Bosutinib single agent group
Arm Type
Other
Arm Description
Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib
Arm Title
Bosutinib-asciminib switch group
Arm Type
Experimental
Arm Description
Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study
Arm Title
Asciminib in combination with imatinib group
Arm Type
Experimental
Arm Description
Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Arm Title
Asciminib in combination with nilotinib group
Arm Type
Experimental
Arm Description
Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Arm Title
Imatinib single agent group
Arm Type
Other
Arm Description
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib
Arm Title
Nilotinib single agent group
Arm Type
Other
Arm Description
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib
Arm Title
Asciminib in combination with dasatinib group
Arm Type
Experimental
Arm Description
Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib
Intervention Type
Drug
Intervention Name(s)
Asciminib single agent
Other Intervention Name(s)
ABL001
Intervention Description
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Intervention Type
Drug
Intervention Name(s)
Asciminib
Other Intervention Name(s)
ABL001
Intervention Description
Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
STI571
Intervention Description
Taken orally, once daily, in the morning with low-fat meal
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Other Intervention Name(s)
AMN107
Intervention Description
Taken orally, twice daily, on an empty stomach
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Taken orally, once daily, with food
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Primary Outcome Measure Information:
Title
Number of participabts with adverse events (AEs) and serious adverse events (SAEs)
Description
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Percentage of participants with clinical benefit as assessed by Investigator
Description
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Michigan Med University of Michigan .
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109 5271
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy McCullough
Email
ntsai@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Moshe Talpaz
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalisa Espinosa
Phone
646-497-9068
Email
espinosD@mskcc.org
First Name & Middle Initial & Last Name & Degree
Michael Mauro
Facility Name
Oregon Health Sciences University .
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Skyler Foley
Phone
+1 503 346 7894
Email
foleysk@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Michael Charles Heinrich
Facility Name
Uni of TX MD Anderson Cancer Cntr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-792-2921
First Name & Middle Initial & Last Name & Degree
Koji Sasaki
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403 000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brno-Bohunice
ZIP/Postal Code
639 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Uijeongbu si
State/Province
Gyeonggi Do
ZIP/Postal Code
11759
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Jeollanam
ZIP/Postal Code
519763
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 776
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50 367
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1099 023
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hospitalet de LLobregat
State/Province
Catalunya
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Asciminib Roll-over Study

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