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Iadademstat + Gilteritinib for Acute Myeloid Leukemia (FRIDA Trial)
FRIDA Trial Summary
This trial is testing a new combination of drugs to treat FLT3-mutated R/R AML. The goal is to find the highest dose of the drugs that is still safe, and to see how well the combination works.
FRIDA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFRIDA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FRIDA Trial Design
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Who is running the clinical trial?
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- I can take care of myself and perform daily activities.I cannot take gilteritinib according to its usage instructions.My liver and kidney functions are normal.I haven't had major surgery or radiation therapy in the last 4 weeks.I can swallow pills.I do not have any ongoing serious infections.I have been diagnosed with acute promyelocytic leukemia.My blood pressure or diabetes is not well-managed.I have been diagnosed with AML or AML with changes related to myelodysplasia.My leukemia is BCR-ABL positive.My leukemia has specific FLT3 mutations.My AML developed after chemotherapy for another cancer, not including MDS.I am a male and will practice abstinence or use effective contraception.I have not been treated with iadademstat or FLT3 inhibitors, except for sorafenib or midostaurin.I have undergone 3 or more treatments for acute myeloid leukemia.I have active brain leukemia or had a severe reaction to medication affecting my brain.My AML has not responded to or has come back after 2 treatments.I am a woman who is postmenopausal, surgically sterile, using two contraceptives, or not sexually active, and I have a negative pregnancy test.My AML has returned for the first or second time, or is not responding to treatment.
- Group 1: Active arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants currently being accepted for this trial?
"According to clinicaltrials.gov, this clinical trial is no longer actively enrolling participants at present time. Originally posted on October 15th 2022 and most recently updated on September 15th 2022; while the study is not taking any more patients, there are still 1466 other trials that are currently recruiting individuals."
When used medicinally, what potential risks does Iadademstat present?
"The safety of Iadademstat was rated as 1, due to its Phase 1 status and the lack of significant data backing up both efficacy and safety."
What does the research team hope to accomplish through this experiment?
"Primary outcomes of this 18 month study include monitoring laboratory values and adverse events. Secondary measures will assess the transplantation rate, overall response rates, and transfusion independence percentages."
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