Study Summary
This trial is testing the side effects and best dose of CPX-351 in combination with quizartinib to treat acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351 contains chemotherapy drugs daunorubicin and cytarabine, which work in different ways to stop the growth of cancer cells. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control these diseases.
- Acute Recurrent Myeloid Leukemia
- Acute Myeloid Leukemia
- Refractory Myelodysplastic Syndromes
- Bone Marrow Blast Count of 10 Percent or Higher
- Myelodysplastic Syndrome
- Refractory Acute Myelogenous Leukemia
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: From treatment start till death or last follow-up id the patients is alive, assessed up to 5 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Treatment (CPX-351, quizartinib)
1 of 1
Experimental Treatment
52 Total Participants · 1 Treatment Group
Primary Treatment: Liposome-encapsulated Daunorubicin-Cytarabine · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Jentzsch, Madlen, Juliane Grimm, Marius Bill, Dominic Brauer, Donata Backhaus, Karoline Goldmann, Julia Schulz, Dietger Niederwieser, Uwe Platzbecker, and Sebastian Schwind. 2020. “ELN Risk Stratification and Outcomes in Secondary and Therapy-related AML Patients Consolidated with Allogeneic Stem Cell Transplantation”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/s41409-020-01129-1.
- 2020. "Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04128748.
Frequently Asked Questions
What are Liposome-encapsulated Daunorubicin-Cytarabine's most common uses?
"Daunorubicin-Cytarabine liposome-encapsulated is used for treating acute myelocytic leukemia, as well as blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis of meningeal leukemia." - Anonymous Online Contributor
How many volunteers are helping to progress this research?
"That is correct. The information available on clinicaltrials.gov verifies that this study, which was first announced on 5/27/2020, is still looking for subjects. In total, 52 individuals are needed across a single location." - Anonymous Online Contributor
Are there any available positions for volunteers in this clinical research?
"Yes, this study is recruiting patients at present. It was originally posted on clinicaltrials.gov on May 27th, 2020 and has been edited most recently on September 30th, 2022." - Anonymous Online Contributor
Could you please share how many times Liposome-encapsulated Daunorubicin-Cytarabine has been tested in the past?
"As of now, there are 280 ongoing clinical trials evaluating Liposome-encapsulated Daunorubicin-Cytarabine. Out of those, 68 are in Phase 3. New York City has the most active studies for this treatment (12538 total), though the majority of these are based in one city within the state." - Anonymous Online Contributor