ACTIVE_NOT_RECRUITING

CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old

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Conditions

Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid Leukemia With Myelodysplasia-Related ChangesSecondary Acute Myeloid LeukemiaTherapy-Related Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Official Title

A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Quick Facts

Study Start:2021-07-29
Study Completion:2027-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04269213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed:
  2. * Therapy-related acute myeloid leukemia (AML)
  3. * AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
  4. * AML with MDS-related changes (as per World Health Organization \[WHO\])
  5. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
  6. * Plasma creatinine =\< 1.5 x upper limit of normal (ULN)
  7. * Total bilirubin \< 2.0 mg/dL
  8. * Serum alanine aminotransferase and aspartate aminotransferase \< 3 x ULN
  9. * Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition \>= 50%
  10. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  11. * Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control
  12. * Men must use a latex condom during any sexual contact with women of childbearing potential
  13. * Willing to adhere to protocol specific requirements
  14. * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  1. * Prior treatment of AML
  2. * Known clinically active central nervous system (CNS) leukemia
  3. * Core-binding factor leukemia
  4. * Acute promyelocytic leukemia
  5. * Uncontrolled other malignancy
  6. * Prior anthracycline exposure \> 368 mg/m\^2 of daunorubicin or equivalent
  7. * Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
  8. * Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs
  9. * Known active HIV infection
  10. * Known history of active hepatitis B or C infection
  11. * Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
  12. * Evidence of ongoing, uncontrolled systemic infection
  13. * Pregnant or breastfeeding women
  14. * Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
  15. * History of Wilson disease or other copper-handling disorders
  16. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Contacts and Locations

Principal Investigator

Steven Green, MD
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
SUNY Upstate Medical Center
Syracuse, New York, 13210
United States
Allegheny Health Network Cancer Institute - West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Steven Green, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-29
Study Completion Date2027-01-29

Study Record Updates

Study Start Date2021-07-29
Study Completion Date2027-01-29

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Acute Myeloid Leukemia With Myelodysplasia-Related Changes
  • Secondary Acute Myeloid Leukemia
  • Therapy-Related Acute Myeloid Leukemia