Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03826992|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Vyxeos Drug: Venetoclax||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia|
|Actual Study Start Date :||December 27, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: Venetoclax and Vyxeos combination
Venetoclax will be given orally on Days 1-21 per the assigned dose level. A single course consisting of 3 doses of Vyxeos and 21 doses of venetoclax will be administered to participants in this study. Vyxeos will be administered by central venous catheter over 90 minutes on Day 1, 3, and 5.
Venetoclax is given daily by mouth per assigned dose level.
Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
Other Name: cytarabine and daunorubicin liposome, CPX-351
Other Name: Venclexta
- Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities) [ Time Frame: 28 days ]If 2 or more participants have dose limiting toxicities at a given dose level, the maximum tolerated dose will have been exceeded.
- Treatment related toxicities [ Time Frame: 60 days ]Number of related adverse events
- Disease response [ Time Frame: 42 days ]Estimate of overall response rate (ORR) defined as (CR/CRi/CRp).
- Cancer therapeutics-related cardiac dysfunction (CTRCD) in patients who have previously received anthracyclines [ Time Frame: 60 days ]Measured by echocardiogram (ECHO)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826992
|Contact: Site Pulblic Contactfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Site Public Contact 513-636-2799 email@example.com|
|Principal Investigator: Michael Absalon, MD, PhD|
|Principal Investigator: Laura Agresta, MD|
|Principal Investigator:||Michael Absalon, MD, PhD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Laura Agresta, MD||Children's Hospital Medical Center, Cincinnati|