A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL

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)

ClinicalTrials.gov Identifier: NCT02081378

Novartis Reference Number: CABL001X2101

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.

Condition 
Chronic Myelogenous Leukemia
Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
330 participants
Start date 
Apr 24, 2014
Completion date 
Mar 14, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
ABL001
ABL001 will be administered orally in a dose escalation schedule.
Drug
ABL001 + Nilotinib
ABL001 and Nilotinib will be administered orally in CML patients
Drug
ABL001
ABL001 will be administered orally in Ph+ ALL patients
Drug
ABL001+imatinib
ABL001 and imatinib will be administered orally in CML patients
Drug
ABL001+dasatinib
ABL001+dasatinib will be administered orally in CML patients

Eligibility Criteria

Inclusion Criteria:

For CML patients either:

a. Patients with Ph+ CML in chronic or accelerated phase who were previously treated with at least two different tyrosine kinase inhibitors prior to study entry and are relapsed, refractory to or intolerant of TKIs as determined by investigators or
b. Patients with CML in chronic or accelerated phase who exhibit relapsed disease associated with the presence of the T315I "gatekeeper mutation" after at least one TKI are also eligible provided that no other effective therapy exists

For ALL and CML-BP patients:

Patients with CML BP or Ph+ ALL who have a cytopathologically confirmed diagnosis and are relapsed or refractory to at least one prior TKI or intolerant of TKIs. TKI failure for Ph+ ALL and CML-BP patients is defined as at least the loss of Molecular Response (MR) 4.5 (BCR-ABL ≤ 0.0032%)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Willingness and ability to comply with all study procedures
Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

Wash-out period:

Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
Therapy with TKIs as single agent within 5 half-lives before the first dose of study treatment
Unconjugated monoclonal antibody therapies within 28 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
For patients receiving ABL001 in combination with either nilotinib or imatinib or dasatinib, intolerance to nilotinib, imatinib or dasatinib, respectively
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment.
CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months previously. At least four weeks must have elapsed since prophylactic CNS irradiation given as part of a front-line therapy regimen for ALL
Major surgery within 2 weeks before the first dose of study treatment

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Dana Farber Cancer Institute Hematology / Oncology
Recruiting
Boston, 02215
Massachusetts
United States
University of Michigan Comprehensive Cancer Center SC
Recruiting
Ann Arbor, 48109
Michigan
United States
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering
Recruiting
New York, 10065
New York
United States
Oregon Health and Science University SC-6
Recruiting
Portland, 97239
Oregon
United States
University of Texas/MD Anderson Cancer Center UT MD Anderson
Recruiting
Houston, 77030-4009
Texas
United States
Huntsman Cancer Institute SC
Recruiting
Salt Lake City, 84112
Utah
United States
Australia
Novartis Investigative Site
Recruiting
Adelaide, 5000
South Australia
Australia
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
Cedex 10
France
Novartis Investigative Site
Recruiting
Bordeaux, 33076
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Jena, 07740
-
Germany
Italy
Novartis Investigative Site
Recruiting
Roma, 00161
RM
Italy
Japan
Novartis Investigative Site
Active, not recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1081 HV
-
Netherlands
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Madrid, 28006
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-999-669-6682 or email [email protected]