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Liposomal Daunorubicin-Cytarabine + Venetoclax for Acute Myeloid Leukemia
Study Summary
This trial is testing how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating people with acute myeloid leukemia.
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.Side effects data
From 2020 Phase 2 trial • 56 Patients • NCT02286726Trial Design
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Who is running the clinical trial?
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- I am 18 or older with AML that has come back or didn’t respond to treatment, including prior venetoclax treatment.I am not pregnant or breastfeeding.I do not have any severe illnesses that could interfere with the study.My leukemia is either acute promyelocytic (M3) or core-binding factor.I am willing to use contraception during the study.I do not have active leukemia in my brain or spinal cord.I can take care of myself but might not be able to do heavy physical work.I am not pregnant and can prove it with a test taken in the last week.I understand the study's requirements and have signed the consent form.I am 18 or older with AML that has come back or didn’t respond to treatment.I am between 18 and 69 years old and have not received any treatment for AML.I've had treatments like hydroxyurea or ATRA without needing a break before joining this trial.I have previously been treated with CPX-351 or venetoclax for my relapsed or refractory disease.
- Group 1: Treatment (CPX-351, venetoclax)
- 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
To what conditions has Liposome-encapsulated Daunorubicin-Cytarabine been found to be most efficacious?
"Liposome-encapsulated Daunorubicin-Cytarabine is usually prescribed for acute myelocytic leukemia. It may also be used to treat blast phase chronic myelocytic leukemia, lymphoma, and meningeal leukemia prophylaxis."
Have any analogous studies been conducted regarding Liposome-encapsulated Daunorubicin-Cytarabine?
"Currently, there are 89 Phase 3 trials involving Liposome-encapsulated Daunorubicin-Cytarabine and 452 active studies in total. Toronto is the main hub of research related to this topic; however, it's being tested at 19158 sites worldwide."
Are individuals able to enroll in this medical trial at the present moment?
"According to clinicaltrials.gov, this trial is recruiting patients as of now. It was initially posted on October 29th 2018 and its most recent edit was done July 8th 2022."
How many participants can join this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting patients; it was initially posted on October 29th 2018 and last modified on July 8th 2022. There are a total of 52 participants needed from a single site."
Has the FDA granted authorization for Liposome-encapsulated Daunorubicin-Cytarabine?
"As this is a Phase-2 study, and although there are some safety data available, the efficacy of Liposome-encapsulated Daunorubicin-Cytarabine has yet to be clinically established. So it was assigned a score of 2."
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