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New treatment option for Acute Myeloid Leukemia With FLT3/ITD Mutation
Official title Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
ClinicalTrials.gov ID: NCT05024552
What this study is testing
What is Gilteritinib?
Gilteritinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia with flt3/itd mutation.
Also referred to as Xospata.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy
- FLT3 testing must be confirmed at the time of disease relapse
You likely can't join if
- Patients may not be receiving any other investigational agents
- Patients with documented central nervous system involvement of AML
- Progression of AML while on prior gilteritinib therapy
- Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications
- Major surgery within two weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than two...
- WBC count ≥50,000 at the time study treatment begins. Use of hydroxyurea to maintain WBC \<50,000 is allowed up to the time that study treatment...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy
- FLT3 testing must be confirmed at the time of disease relapse
- Adequate organ function
- Left ventricular ejection fraction (LVEF) ≥50%
- Prior anthracycline exposure ≤368 mg/m2 daunorubicin (or equivalent)
- Ability to take oral medication and willingness to adhere to the medication regimen
- For females of reproductive potential: use of highly effective contraception including double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or...
- For females of reproductive potential: negative serum or urine pregnancy test with a sensitivity of at least 50mIU/mL within 10 days and again within 24 hours of beginning study treatment
- For males of reproductive potential: use of condoms
- Breastfeeding mothers must agree to discontinue nursing
- Patients who have relapsed after and allogeneic stem cell transplant must have controlled grade ≤2 GVHD. Immunosuppression with tacrolimus or sirolimus is allowed at stable or tapering doses.
- Patients may not be receiving any other investigational agents
- Patients with documented central nervous system involvement of AML
- Progression of AML while on prior gilteritinib therapy
- Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications
- Major surgery within two weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than two weeks prior
- WBC count ≥50,000 at the time study treatment begins. Use of hydroxyurea to maintain WBC \<50,000 is allowed up to the time that study treatment begins
- Predicted inability to tolerate standard induction chemotherapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- No other malignancies in addition to AML that are currently requiring treatment with the exception of: 1) basal cell or squamous cell carcinoma or the skin; 2) carcinoma in situ of the cervix or breast; 3) a history of...
- Grade ≥3 acute or chronic graft versus host disease after allogeneic stem cell transplant. No steroids for GVHD are allowed.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.