CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]
Study title
CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]
Scientific title
A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) (EudraCT 2013-004491-36, ClinicalTrials.gov NCT02081378)
Type of study
Trial after therapy failure or intolerance
Current status
No longer recruiting
What is the purpose of the study
This first-in-human, open label, dose finding study is conducted to establish a safe and tolerated dose of ABL001 in CML and Ph+ ALL patients who are relapsed or resistant to or are intolerant of TKIs. In these patients, ABL001 may provide a novel therapeutic option.
ABL001 capsules will be administered orally in a dose escalation schedule.
Key inclusion criteria
Patients 18 years and older with Philadelphia chromosome-positive CML in chronic or accelerated phase who were previously treated with two different tyrosine kinase inhibitors (TKIs) and are relapsed, resistant to or intolerant of TKIs.
Adult patients with cytopathologically confirmed Ph+ ALL who are relapsed or resistant to one prior TKI or intolerant of TKIs.
TKI failure for Ph+ ALL patients is defined as at least the loss of Molecular Response (MR) 4.5 (BCR-ABL ≤ 0.0032%).
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
For Germany:
Prof. Dr. Oliver Ottmann
Universitätsklinikum Frankfurt
Study centers / principal investigators
Australia, South Australia
Adelaide, 5000
Novartis Investigative Site
France
Bordeaux, 33076
Novartis Investigative Site
Paris, Cedex 10, 75475
Novartis Investigative Site
Germany
Charité
13353 Berlin
Universitätsklinikum Frankfurt
60590 Frankfurt
Universitätsklinikum Jena
Klinik für Innere Medizin II. Abteilung Hämatologie und Internistische Onkologie
07743 Jena
Italy
Roma, 00161
Novartis Investigative Site
Japan
Kobe-city, Hyogo, 650-0017
Novartis Investigative Site
Korea, Republic of
Seoul, 137-701
Novartis Investigative Site
Netherlands
Amsterdam, 1081 HV
Novartis Investigative Site
Singapore
Singapore, 28006
Novartis Investigative Site
Spain
Madrid, 28006
Novartis Investigative Site
USA
Massachusetts
Dana Farber Cancer Institute
Hematology / Oncology
Boston, 02215
Michigan
University of Michigan Comprehensive Cancer Center SC
Ann Arbor, 48109-0944
New York
Memorial Sloan Kettering Cancer Center
New York, 10065
Oregon
Oregon Health & Science University SC-6
Portland, 97239
Texas
University of Texas
MD Anderson Cancer Center
Houston, 77030-4009
Utah
University of Utah
Huntsman Cancer Institute
Salt Lake City, 84112