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CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL

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)

Indication and most important 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%).

Short description of intervention

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.

Type of study

Trial after therapy failure or intolerance

Current status

recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

For Germanny:
Prof. Dr. Oliver Ottmann
Universitätsklinikum Frankfurt

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

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
10117 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
University of Utah
Huntsman Cancer Institute