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Vyxeos + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Study Summary
This trial is testing a new cancer treatment combining two drugs, to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My AML is classified as high-risk according to ELN 2017.I am willing and able to follow all study rules and attend all appointments.I have an active hepatitis B or C infection.I do not need medication to maintain my blood pressure.My organs are functioning well.I can use hydroxyurea for cytoreduction until my study treatment starts.I have active leukemia in my brain or spinal cord.I can care for myself and my doctor agrees I can handle strong chemotherapy.I have taken HMA therapy for conditions other than AML, with the last dose 14 days before starting this study.I am currently pregnant or breastfeeding.I am between 18 and 70 years old with a certain type of leukemia.I do not have severe heart problems like recent heart attacks or unstable chest pain.I am a woman who can have children and have tested negative for pregnancy before starting the study.I do not have severe liver disease or Wilson's disease.I am using effective birth control and will continue for 6 months after treatment ends.My heart pumps well, with an ejection fraction of 50% or higher.My total anthracycline dose hasn't exceeded the limit, even with prior treatments.I am a man who can father children and will use contraception.I have had cancer before, but it doesn't need treatment now. Hormone therapy is okay.My blood cancer cells test positive for CD33.My cancer has a FLT3 mutation.I have received treatments for AML, but only hydroxyurea or leukapheresis.I am allergic to CPX-351 or Gemtuzumab ozogamicin.I have been diagnosed with acute promyelocytic leukemia.
- Group 1: Dose Escalation
- 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
Does your research encompass subjects aged sixty and above?
"This trial is available for participants aged 18 to 70. Furthermore, the clinic offers 450 trials for minors and 1231 studies for seniors."
To what extent is this trial's participant pool currently being populated?
"Affirmative. The information available on clinicaltrials.gov confirms that this research study is actively seeking participants after being posted on September 22nd 2022 and updated most recently on the 23rd of September. A total of 18 individuals are required for enrolment, all from a single medical facility."
What eligibility criteria must be met for participants of this research?
"This trial is seeking 18 individuals aged between 18 and 70 with a diagnosis of acute myelocytic leukemia. Participants must provide signed consent, be male or female (with the latter needing to use effective contraception), have CD33+ myeloblasts, no concurrent malignancy treatment aside from hormone therapy, agree to comply with all procedures, demonstrate an ECOG score ≤2 and eligible for intensive chemotherapy as deemed by their physician. In addition, males of reproductive potential must use condoms or other contraceptive methods when engaging in intimate activities while females need to produce a negative serum/urine pregnancy test within 24 hours prior to starting study treatment if"
Is this research project still open to new participants?
"Indeed, the information stored on clinicaltrials.gov demonstrate that this trial is actively recruiting. It was first posted 22nd September 2022 and last altered 23rd of September 2022; 18 participants are needed from one medical site."
What hazards have been identified with administering higher doses of medication?
"The limited evidence surrounding Dose Escalation's safety and efficacy warrants its score of 1."
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