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Trial details
A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors
Current status:
Approved
|
Date registered:
14/08/2019
Trial version(s)
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
History: 22/01/2019
Current: 22/01/2019
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Main Information
Primary registry identifying number
LBCTR2019010185
Protocol number
CABL001A2301
MOH registration number
49983/2017
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was already initiated, original file was previously submitted
Date of registration in national regulatory agency
21/12/2017
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors
Acronym
ASCEMBL
Scientific title
A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors
Acronym
Brief summary of the study: English
The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs with BCR-ABL ratios ≥ 1% IS at screening.
Brief summary of the study: Arabic
دراسة جزافيّة في المرحلة 3 مفتوحة اللصاقة، متعددة المراكز حول دواء ABL001 عن طريق الفم مقابل دواء بوسوتينيب لدى المرضى المصابين بسرطان الدم النقوي المزمن في المرحلة المزمنة، المعالجين سابقًا بمثبّطَيْن أو أكثر لكيناز التيروزين
Health conditions/problem studied: Specify
Chronic Myelogenous Leukemia
Interventions: Specify
ABL001, Bosutinib
Key inclusion and exclusion criteria: Inclusion criteria
Male or female patients with a diagnosis of CML-CP ≥ 18 years of age Patients must meet all of 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 BCR-ABL1 ratio ≥ 1% IS according to central laboratory at the screening examination Prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib, dasatinib, radotinib or ponatinib) Failure (adapted from the 2013 ELN Guidelines Bacarrani 2013) or intolerance to the most recent TKI therapy at the time of screening •Failure is defined for CML-CP patients (CP at the time of initiation of last therapy) as follows. Patients must meet at least 1 of the following criteria. •Three months after the initiation of therapy: No CHR or > 95% Ph+ metaphases •Six months after the initiation of therapy: BCR-ABL1 ratio > 10% IS and/or > 65% Ph+ metaphases •Twelve months after initiation of therapy: BCR-ABL1 ratio > 10% IS and/or > 35% Ph+ metaphases •At any time after the initiation of therapy, loss of CHR, CCyR or PCyR •At any time after the initiation of therapy, the development of new BCR-ABL1 mutations which potentially cause resistance to study treatment •At any time after the initiation of therapy, confirmed loss of MMR in 2 consecutive tests, of which one must have a BCR-ABL1 ratio ≥ 1% IS •At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells: CCA/Ph+ •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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Known presence of the T315I or V299L mutation at any time prior to study entry Known second chronic phase of CML after previous progression to AP/BC Previous treatment with a hematopoietic stem-cell transplantation Patient planning to undergo allogeneic hematopoietic stem cell transplantation Cardiac or cardiac repolarization abnormality, including any of the following: • History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) • Clinically significant cardiac arrhythmias • QTcF at screening ≥450 msec (male patients), ≥460 msec (female patients) • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: • Risk factors for Torsades de Pointes (TdP) • Concomitant medication(s) with a known risk of Torsades de Pointes per www.qtdrugs.org that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication. • Inability to determine the QTcF interval • Severe and/or uncontrolled concurrent medical disease • History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis • History of acute or chronic liver disease • Treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with study treatment • Moderate or strong inducers of CYP3A • Moderate or strong inhibitors of CYP3A and/or P-gp • Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 3 days after last dose of ABL001. • Sexually active males unless they use a condom during intercourse while taking the drug during treatment and for 3 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via semen.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Other
Study design: Specify assignment
2:1
IMP has market authorization
No
Name of IMP
ABL001
Type of IMP
Cell therapy
Pharmaceutical class
orally bioavailable specific BCR-ABL inhibitor with a novel mechanism of action.
Therapeutic indication
patients with Chronic Myelogenous Leukemia-CP who had prior treatment with two or more ATP binding site TKIs
Therapeutic benefit
increase OS & PFS
Biospecimen retention
Samples without DNA
Biospecimen description
Bone marrow aspirate samples, Hematology , chemistry , coagulation, hepatitis , Liver function tests , are sent to Covance central laboratory, Navigate biopharma, molecular MD and Histogene X .
Target sample size
5
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
05/09/2018
Date of study closure: Type
Actual
Date of study closure: Date
21/12/2022
Recruitment status
Recruiting
Date of completion
29/02/2020
IPD sharing statement plan
Yes
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03106779?id=cabl001a2301&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical Trials.Gov
NCT03106779
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Bazarbachi
Beirut
Lebanon
009613612434
bazarbac@aub.edu.lb
American University of Beirut Medical Center
Scientific
Hind
Khairallah
Beirut
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Joseph
Kattan
Beirut
Lebanon
009613635913
jkattan62@hotmail.com
Hotel Dieu De France
Public
Dany
ABi Gerges
Mansourieh
Lebanon
009613341960
abgerges@idm.net.lb
Bellevue Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Bellevue Medical Center
Dr Dany Abi Gerges
Hematology Oncology
Approved
American University of Beirut Medical Center
Dr. Ali Bazarbachi
Hematology Oncology
Approved
Hotel Dieu De France
Dr Joseph Kattan
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
05/06/2018
Fuad Ziyadeh
fz05@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Hotel Dieu de France
02/10/2017
Nancy Alam
nancy.alam@usj.edu.lb
+961 1421000 ext 2335
Bellevue Medical Center
23/11/2017
Ghassan Maalouf
gmaalouf@bmc.com.lb
+961 1 682666 ext 7600
Countries of Recruitment
Name
Lebanon
Argentina
Australia
Belgium
Bulgaria
Canada
Czech Republic
France
Germany
Hungary
Italy
Japan
Republic of Korea
Netherlands
Turkey
United States of America
Saudi Arabia
United Kingdom
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic Myelogenous Leukemia
Leukaemia, unspecified (C95.9)
CML
Interventions
Intervention
Description
Keyword
Physical examination, Vital Sign, Height and weight, ECOG performance status, Laboratory chemistry and hematology, Serology, Electrocardiogram (ECG), Echocardiogram, Pulmonary function tests, PK sampling (full/sparse), Bone Marrow Biopsy, Patient Report Outcomes (MDASI-CML, PGIC, WPAI, EQ--5D-5L, resource
ICF, Lab tests, physical examination, ECG
Lab, ECG, ICF, BMA
Primary Outcomes
Name
Time points
Measure
Major Molecular Response (MMR) rate
24 weeks
24 wks
Key Secondary Outcomes
Name
Time points
Measure
Major Molecular Response (MMR) rate
96 weeks after the last patient received the first study dose
96 weeks after first dose
Complete Cytogenetic response rate
24,48,96 weeks
24,48,96 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial