leukemia
Conditions
Interventions
Treatment with ABL001 as single agent and in combination with nilotinib,
dasatinib en imatinib.
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of dose limiting toxicities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main efficacy endpoint : MMR rate by 24 weeks of treatment Secondary efficacy endpoints : Hematologic, cytogenic, molecular response, plasma concentration, changes in pSTAT5 and pCRKL, adverse effects. | — |
Countries
Netherlands
Outcome results
None listed