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Home»Leukemia» Looking for patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lympholastic leukemia to test a BCR-ABL1 inhibitor
Clinical Trial
Looking for patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lympholastic leukemia to test a BCR-ABL1 inhibitor
This phase 1 clinical trial will test the safety of ABL001 alone and with either nilotinib (Tasigna), imatinib(Gleevec), or dasatinib(Sprycel)in patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic Leukemia (Ph+ALL). The primary outcome will be measured by side effects.
The details
ABL001, nilotinib, imatinib, and dasatinibare all inhibitors of the ABL1 tyrosine kinase. Tyrosine kinases are cellular proteins that relay signals for growth and division. Patients with CML or ALL often have mutated versions of the ABL1 kinase (due to the Philadelphia chromosomal abnormality) in myeloid cells, called BCR-ABL1. This causes the protein to be overactive, which results in uncontrolled growth and leads to cancer. These drugs inhibit (blocks the function of) BCR-ABL1 proteins to stop cell division and promote the death of cancer cells. It is unclear which treatment or treatments will provide the greatest response.
The study will examine dose-limiting side effects (negative side effects prevent further dose increase) for 28 days in patients treated with ABL001 alone or in combination with other treatments. The trial will also consider response to treatment, adverse (negative) side effects, and concentrations of the drugs in the plasma (blood without cells).
Who are they looking for?
This trial is recruiting 250 patients with relapsed or refractory (unresponsive to treatment) CML or Ph+ALL. Patients with Ph+CML should have received at least two prior tyrosine kinase inhibitors. Those with T315I positive CML, blast phase CML, or ALL should have been treated with at least one prior tyrosine kinase inhibitor.
Participants should not have received systemic anticancer therapy within 14 days or monoclonal antibodies within 28 days prior to enrollment. Candidates should not have received central nervous system irradiation for meningeal leukemia unless it occurred over 3 months prior to entry.
How will it work
Patients with CML will be divided into 4 treatment groups: ABL001 only, ABL001 and nilotinib, ABL001 and imatinib, and ABL001 and dasatinib.
Patients with Ph+ ALL will receive ABL001 only. All of the drugs will be taken by mouth in increasing doses until the maximum tolerated dose is determined.
