- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04269213
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Nebraska
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Vijaya Bhatt, MD
- Phone Number: 402-559-8500
- Email: vijaya.bhatt@unmc.edu
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Steven Green, MD
- Phone Number: 716-845-8387
- Email: Steven.Green@roswellpark.org
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Allegheny Health Network Cancer Institute - West Penn Hospital
-
Contact:
- Salman Fazal, MD
- Phone Number: 412-578-4484
- Email: Salman.Fazal@ahn.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Known active HIV infection
- Known 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (CPX-351)
INDUCTION: 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. |
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])
Time Frame: At day 45
|
Defined by the International Working Group Criteria.
Will be summarized using frequencies and relative frequencies.
|
At day 45
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR + CRi duration
Time Frame: Time from CR or CRi until relapse or last follow-up, assessed up to 5 years
|
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
|
Time from CR or CRi until relapse or last follow-up, assessed up to 5 years
|
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
|
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
|
Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years
|
Overall survival
Time Frame: Time from treatment until death due to any cause or last follow-up, assessed up to 5 years
|
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
|
Time from treatment until death due to any cause or last follow-up, assessed up to 5 years
|
Allogeneic hematopoietic cell transplant rate
Time Frame: Up to 5 years
|
Transplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.
|
Up to 5 years
|
Incidence of adverse events
Time Frame: Up to 5 years
|
Will be reported by grade using frequencies and relative frequencies.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven Green, MD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Neoplastic Processes
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
Other Study ID Numbers
- I 501719 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2019-08946 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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