A phase I, multicenter, open-label study of oral ABL001 in patients with chronic myelogenous leukemia or Philadelphia Chromosome-positive acute lymphoblastic Leukemia (CABL001X2101)
- Conditions
- leukemiachronic myelogenous leukemia/Philadelphia chromosome-positive acute lymphoblastic leukemia10024324
- Registration Number
- NL-OMON55523
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• Male or female patients at least 18 years of age.
• CML in chronic or accelerated phase who were previously treated with two
different tyrosine kinase inhibitors prior to study entry and are relapsed,
refractory to or intolerant of TKIs as determined by investigators
Or
Philadelphia chromosome-positive ALL and be relapsed or refractory to one prior
TKI or intolerant of TKIs.
See protocol page 26-27 for further details.
• ECOG performance status 0-2.
• Systemic antineoplastic therapy or any experimental therapy within 14 days or
5 half-lives, whichever is longer, before the first dose of ABL001
For patients receiving ABL001 in combination with either nilotinib, or imatinib
or dasatinib, intolerance to nilotinib, imatinib or dasatinib, respectively
• Radiotherapy within 1-4 weeks of the first dose of ABL001. See protocol page
27 for details.
• CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3
months previously.
• Clinical laboratory results: see protocol page 27-28.
• Active infection.
• History of significant bleeding disorder unrelated to cancer.
• History of acute pancreatitis within 1 year of study entry, chronic
pancreatitis, or any ongoing pancreatic disease not considered related to the
malignancies under study.
• Pregnant or lactating women.
• Women of child-bearing potential using inadequate contraception. See protocol
page 28-29 for details.
• Males in arm 4 must use a condom during intercourse while taking the drug and
for 30 days after stopping treatment and should not father a child in this
period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of dose limiting toxicities.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Main efficacy endpoint : MMR rate by 24 weeks of treatment<br /><br>Secondary efficacy endpoints : Hematologic, cytogenic, molecular response,<br /><br>plasma concentration, changes in pSTAT5 and pCRKL, adverse effects.</p><br>