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Home»Leukemia» Looking for patients who are ineligible for intensive induction chemo to test ASP2215 alone or with azacitidine in treating newly diagnosed acute myeloid leukemia
Clinical Trial
Looking for patients who are ineligible for intensive induction chemo to test ASP2215 alone or with azacitidine in treating newly diagnosed acute myeloid leukemia
This phase 2/3 clinical trial will test the effectiveness of gilteritinib (ASP2215) with or without azacitidine (Vidaza) versus azacitidine alone in treating newly diagnosed acute myeloid leukemia (AML) patients with FLT3 mutation. The primary outcome will be measured by the overall survival.
The details
ASP2215 is is an inhibitor of the FLT3 receptor tyrosine kinase. Receptor tyrosine kinases are proteins that relay signals cell growth and division. Patients with AML may have mutated versions of the FLT3 protein. This to uncontrolled cell growth. Blocking the function of FLT3 with ASP2215 may help stop the spread of cancer and result in cancer cell death. Azacytidine is a chemotherapy that leads to cancer cell death. It is unclear whether ASP2215 alone or with azacytidine, will increase the AML response rate.
The study will examine the overall survival rate, response rate, time without any cancer symptoms, and safety of the treatment for 36 months.
Who are they looking for?
This trial is recruiting 540 patients with FLT3 positive AML who are ineligible for an intensive induction chemotherapy. Patients must have adequate liver function. Men and women must agree to use contraception during and for up to 120 days after the end of the study.
Candidates should not have undergone major surgery or radiotherapy within 4 weeks prior to entry. Patients should not have central nervous system involvement with AML, another malignancy that requires treatment, class 4 congestive heart failure, or pulmonary disease. Participants should not have an active infection, including HIV.
How will it work
Initially, 8 to 12 patients will be enrolled to test the tolerability of ASP2215 with azacytidine. ASP2215 will be taken daily by mouth throughout a 28-day cycle andsubcutaneous (injection under the skin) or intravenous (IV) azacytidine will be given on days 1-7 of the cycle.
Approximately 528 patients will then be divided into 3 groups. Group 1 will be given ASP2215 only, group 2 will receive ASP2215 and azacytidine, and group 3 will receive azacitidine only. Each drug will be given as it was in the initial part of the trial.
