- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04990102
Phase IB/II of CPX-351 for Relapse Prevention in AML
October 27, 2023 updated by: Georgetown University
Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation
This is a phase IB/II study with a 3+3 dose de-escalation study design.
Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR.
The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity.
The maximum tolerated dose will be used for the phase II expansion portion of the study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Recruiting
- Georgetown Lombardi Comprehensive Cancer Center
-
Principal Investigator:
- Kimberley Doucette, MD
-
Contact:
- Thomas White
- Phone Number: 202-687-9194
- Email: thomas.white@georgetown.edu
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center
-
Principal Investigator:
- James McCloskey, MD
-
Contact:
- Lumi Demirovic
- Phone Number: 551-996-8154
- Email: Ljumnije.demirovic@hmhn.org
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Principal Investigator:
- Catherine Lai, MD
-
Contact:
- Ashlena Livingston
- Phone Number: 267-357-2228
- Email: robin.blauser@pennmedicine.upenn.edu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Newly diagnosed patients > 18 years of age
- Patients must be in CR or CRh (complete remission with partial count recovery).
- Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than one year of treatment.
- Must be able to start therapy within 3 months of last documented CR
- De novo or secondary AML/treatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed
- Patients must be ineligible for allogeneic BMT (for any reason including poor performance status, patient's preference, favorable AML not a candidate for transplant, or comorbidities and age precluding from transplant etc)
- Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan
Adequate hepatic and renal function defined as:
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 is permissible if due to disease.
- Bilirubin ≤3 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
- Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault based on actual weight) (See Appendix A)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 (Appendix A)
- Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.
- Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for at least 6 months after the last dose of study drug
Exclusion Criteria:
- Prior allogeneic transplant
- Previous cumulative anthracycline (doxorubicin equivalent) dose equal to or greater than 345 mg/m2, and for patients with prior mediastinal XRT, anthracycline dose equal to or greater than 295 mg/m2
- Acute promyelocytic leukemia [t(15;17)]
- If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness
- Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
- History of Wilson's disease or other copper-related disorders
- History of allergic reactions attributed to compounds of similar composition to cytarabine and daunorubicin or liposomal products
History of other malignancies, except:
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade ≤1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia.
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
- Known active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
- Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, must have a negative polymerase chain reaction (PCR) result for the respective disease before enrollment. Those who are PCR positive will be excluded.
- Any uncontrolled active systemic infection.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
- Known CNS involvement by leukemia
- Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
- Lactating or pregnant.
- Unwilling or unable to participate in all required study evaluations and procedures.
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
- Currently active, clinically significant hepatic impairment (≥ moderate hepatic impairment according to the Child Pugh classification (class B or C))
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPX-351
Dose Level 1: CPX-351 administered through intravenou infusion on Day 1 and Day 3 of 28 day cycle for 6 cycles or Dose Level -1: CPX-351 administered through intravenous infusion on Day 1 of each 28 day cycle for 6 cycles.
|
Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerate dose (Phase 1)
Time Frame: 1 cycle (28 day cycle)
|
Number of subjects with Dose Limiting toxicities will be used to determine the recommended phase II dose of CPX-351 to be used in the maintenance setting for newly diagnosed AML in complete remission.
|
1 cycle (28 day cycle)
|
Inicidence of Treatment Emergent Adverse events (Phase 2)
Time Frame: 6 cycles (28 day cycles)
|
To determine the safety, tolerability and toxicity of CPX-351 in the maintenance setting for newly diagnosed AML in complete remission by analyzing the incidence of treatment emergent adverse events reported.
|
6 cycles (28 day cycles)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment Emergent Adverse Events (Phase 1)
Time Frame: 6 cycles (28 day Cycle)
|
To determine the safety, tolerability and toxicity of CPX-351 in the maintenance setting for newly diagnosed AML in complete remission by analyzing the incidence of treatment emergent adverse events reported.
|
6 cycles (28 day Cycle)
|
Overall Survival (Phase 1 and 2)
Time Frame: 1 year after end of treatment
|
Determine the efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by overall survival of subjects.
|
1 year after end of treatment
|
Event free survival (Phase 1 and 2)
Time Frame: 1 year after end of treatment
|
Determine efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by event free survival.
|
1 year after end of treatment
|
Relapse Free Survival (Phase 1 and 2)
Time Frame: 1 year after end of treatment
|
Determine efficacy of CPX-351 as maintenance treatment in newly diagnosed AML patients who have achieved remission after induction treatment as measured by relapse free survival.
|
1 year after end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kimberley Doucette, MD, Georgetown University
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 Major Dates
Study Start (Actual)
May 22, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
July 26, 2021
First Posted (Actual)
August 4, 2021
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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