Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Vyxeos plus gilteritinib for acute myeloid leukemia (AML), a blood cancer with a FLT3 gene change that has come back or did not respond to treatment. Patients whose cancer clears may get more treatment with both drugs. Those who do not get a donor stem cell transplant may continue with daily gilteritinib.
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. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form and agree to follow study steps for the full study.
- Have AML, but not the M3 type, with a FLT3-ITD or FLT3-TKD gene change. The cancer must have returned or not responded to at least one treatment. FLT3 testing must confirm the change when cancer returns.
- Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
- Have organs that work well enough. Your heart must pump out at least 50% of its blood with each beat.
- Have received no more than 368 mg/m² of daunorubicin, or an equal amount of similar chemotherapy drugs.
- Be able to take medicine by mouth and follow the medicine schedule.
- Women who can become pregnant must use highly effective birth control and have negative pregnancy tests within 10 days and again within 24 hours before treatment. Men who can father a child must use condoms. Breastfeeding must stop.
- If AML returned after a donor stem cell transplant, any graft-versus-host disease (GVHD), when donor cells attack your body, must be controlled and grade 2 or lower. Tacrolimus or sirolimus is allowed at stable or decreasing doses.
Who can't join
- Taking another experimental treatment, or having AML that worsened during earlier gilteritinib treatment.
- AML in the brain or spinal cord.
- Digestive tract problems that affect how your body takes in medicine by mouth.
- Major surgery within two weeks before study treatment, or not yet recovered from earlier surgery.
- A white blood cell count of 50,000 or higher when treatment starts. Hydroxyurea may be used to lower it before treatment.
- Being unable to tolerate standard starting chemotherapy, or having an uncontrolled illness, infection, heart problem, mental health condition, or life situation that prevents following study steps.
- Another cancer that needs treatment, except certain skin cancers, cancer limited to its starting area in the cervix or breast, or past breast cancer now managed with hormone treatment.
- Grade 3 or higher GVHD after a donor stem cell transplant, or use of steroids for GVHD.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 injectable contraceptives, intrauterine devices and tubal ligation. * 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. Exclusion Criteria: * 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 that would limit compliance with study requirements * 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 breast cancer that is currently being managed with adjuvant endocrine therapy * Grade ≥3 acute or chronic graft versus host disease after allogeneic stem cell transplant. No steroids for GVHD are allowed.
Study sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Jhada-Kai Hunter · Study contact · 813-745-0286 · Jhada-Kai.Hunter@moffitt.orgOnyee Chan, MD · Principal investigatorBrandon Blue, MD · Sub-investigatorTimothy Kubal, MD, MBA · Sub-investigatorMore trials in Tampa