Clinical Trials /

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

NCT04269213

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome
  • Acute Myeloid Leukemia with Myelodysplasia-Related Changes
  • Therapy-Related Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04269213

Trial Eligibility

Document

Title

  • Brief Title: CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
  • Official Title: A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: I 501719
  • SECONDARY ID: NCI-2019-08946
  • SECONDARY ID: I 501719
  • SECONDARY ID: P30CA016056
  • NCT ID: NCT04269213

Conditions

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

Interventions

DrugSynonymsArms
Liposome-encapsulated Daunorubicin-CytarabineCPX-351, Cytarabine-Daunorubicin Liposome for Injection, Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, VyxeosTreatment (CPX-351)

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the complete response rate including morphologic complete remission (CR) and
      morphologic complete remission with incomplete blood count recovery (CRi) as defined by the
      International Working Group Criteria.

      SECONDARY OBJECTIVE:

      I. To determine CR + CRi duration, event free survival (EFS), overall survival (OS), patients
      successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (AE).

      OUTLINE:

      INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV)
      over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable
      toxicity.

      RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated
      daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease
      progression or unacceptable toxicity.

      CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who
      achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1
      and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days, and then every 3
      months for up to 5 years.

Trial Arms

NameTypeDescriptionInterventions
Treatment (CPX-351)ExperimentalINDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
  • Liposome-encapsulated Daunorubicin-Cytarabine

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed:

               -  Therapy-related acute myeloid leukemia (AML)

               -  AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic
                  leukemia (CMML)

               -  AML with MDS-related changes (as per World Health Organization [WHO])

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Plasma creatinine =< 1.5 x upper limit of normal (ULN)

          -  Total bilirubin < 2.0 mg/dL

          -  Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN

          -  Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >=
             50%

          -  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

          -  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

          -  Men must use a latex condom during any sexual contact with women of childbearing
             potential

          -  Willing to adhere to protocol specific requirements

          -  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

        Exclusion Criteria:

          -  Prior treatment of AML

          -  Known clinically active central nervous system (CNS) leukemia

          -  Core-binding factor leukemia

          -  Acute promyelocytic leukemia

          -  Uncontrolled other malignancy

          -  Prior anthracycline exposure > 368 mg/m^2 of daunorubicin or equivalent

          -  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

          -  Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs

          -  Human immunodeficiency virus (HIV) infection

          -  History of active hepatitis B or C infection

          -  Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic
             steatohepatitis, sclerosing cholangitis)

          -  Evidence of ongoing, uncontrolled systemic infection

          -  Pregnant or breastfeeding women

          -  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

          -  Received an investigational agent within 30 days prior to enrollment

          -  History of Wilson disease or other copper-handling disorders

          -  Any condition which in the investigator's opinion deems the participant an unsuitable
             candidate to receive study drug
Maximum Eligible Age:59 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])
Time Frame:At day 45
Safety Issue:
Description:Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.

Secondary Outcome Measures

Measure:CR + CRi duration
Time Frame:Time from CR or CRi until relapse or last follow-up, assessed up to 5 years
Safety Issue:
Description:Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Measure:Event free survival
Time Frame:Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years
Safety Issue:
Description:Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Measure:Overall survival
Time Frame:Time from treatment until death due to any cause or last follow-up, assessed up to 5 years
Safety Issue:
Description:Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Measure:Allogeneic hematopoietic cell transplant rate
Time Frame:Up to 5 years
Safety Issue:
Description:Transplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.
Measure:Incidence of adverse events
Time Frame:Up to 5 years
Safety Issue:
Description:Will be reported by grade using frequencies and relative frequencies.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Roswell Park Cancer Institute

Last Updated

August 5, 2021