Liposome-encapsulated Daunorubicin-Cytarabine for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndrome+6 MoreLiposome-encapsulated Daunorubicin-Cytarabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new chemotherapy drug to see what the best dose is and what side effects it causes. The drug works by killing cancer cells or stopping them from growing.

Eligible Conditions
  • Refractory Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Atypical Chronic Myeloid Leukemia
  • Bone Marrow Blast Count
  • Chronic Myelomonocytic Leukemia
  • High Risk Chronic Myelomonocytic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Up to 1.5 years

Up to 1.5 years
Duration of response
Incidence of adverse events
Objective response rate (ORR) (dose-expansion stage)
Overall response rate
Overall survival
Relapse-free survival
Up to 28 days
Maximum-tolerated dose (MTD) of liposome-encapsulated daunorubicin-cytarabine (dose-escalation stage)
Up to 30 days
Incidence of adverse events (dose-escalation stage)
Incidence of adverse events (dose-expansion stage)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Side Effects for

Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
25%Febrile Neutropenia
21%Neutropenic Fever
17%Lung Infection
17%Sepsis
13%Insomnia
8%Infection
8%Pericardial Effusion
8%Hypertension
4%Intracranial Hemorrhage
4%Pancreatitis
4%Anxiety
4%Cardiac Disorders
4%Acute Coronary Syndrome
4%Joint Effusion
4%Pleural Effusion
4%Alanine aminotransferase Increase
4%Fever
4%Respiratory Failure
4%Blood Bilirubin Increase
4%Multi-Organ Failure
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02286726) in the Arm II (Intermediate-dose (75 Units/m^2) CPX-351) ARM group. Side effects include: Febrile Neutropenia with 25%, Neutropenic Fever with 21%, Lung Infection with 17%, Sepsis with 17%, Insomnia with 13%.

Trial Design

1 Treatment Group

Treatment (liposome-encapsulated daunorubicin-cytarabine)
1 of 1

Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Liposome-encapsulated Daunorubicin-Cytarabine · No Placebo Group · Phase 1

Treatment (liposome-encapsulated daunorubicin-cytarabine)
Drug
Experimental Group · 1 Intervention: Liposome-encapsulated Daunorubicin-Cytarabine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1.5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,496 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,077 Previous Clinical Trials
41,139,543 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
186 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of MDS or CMML according to WHO criteria.
You are not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment.
You have a serum creatinine clearance of at least 30 mL/min and no end/stage renal disease.
Use of Hydroxyurea is allowed at any time prior to or during study if considered to be in the best interest of the patient.
You must have signed an informed consent document indicating that you understand the purpose of and procedures required for the study and are willing to participate in the study.