- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06182592
A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia
A Randomized, Multi-center, Open-label Phase III Bridging Study to Compare Efficacy of Liposomal Cytarabine-Daunorubicin for Injection With Cytarabine and Daunorubicin in Treating Older Patients With High-Risk (Secondary) Acute Myeloid Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Contact Backup
- Name: Jianxiang Wang
- Phone Number: 86-022-23909120
- Email: wangjx@ihcams.ac.cn
Study Locations
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-
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Tianjin, China
- Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
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Contact:
- Jianxiang Wang, MD
- Phone Number: 86-022-23909120
- Email: wangjx@ihcams.ac.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to understand the study and voluntarily sign informed consent.
- Male or female between 60-75 years of age (inclusive).
Pathological diagnosis of AML according to 2022 WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) and fulfill of one of the following standards:
- Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease;
- AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS;
- AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL;
- De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Laboratory values meet the following criteria:
- Serum creatinine≤2 × ULN;
- Serum total bilirubin≤2 × ULN, ≤3 × ULN for patients with liver involvement;
- Serum alanine aminotransferase or aspartate aminotransferase≤3 × ULN, ≤5 × ULN for patients with liver involvement.
- Cardiac function (LVEF) ≥ 50% by echocardiography or MUGA.
- QTcF (Fridericia's) for male<450 ms, for female<470 ms at screening.
- Male and female of childbearing potential must agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study.
Exclusion Criteria:
- Acute promyelocytic leukemia; or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
- Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- History of other malignancy within 3 years before randomization, expect for cancers that have been cured (basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix and breast or prostate cancer with Gleason score of 6).
- Patients with clinical evidence of active CNS leukemia.
- Prior treatment for AML (except for hydroxyurea) or stem-cell transplantation.
- Administration of any therapy for MDS (conventional or investigational) within 2 weeks prior to of the first dose of study drug; use of hydroxyurea for the purpose of inhibiting rapid tumor proliferation within 24 hours before the first dose. Toxicities associated with prior MDS therapy have not recovered to grade 1 or less prior to start of treatment.
- Any major surgery or radiation therapy within 4 weeks.
- Patients with previous cumulative exposure to anthracyclines >368 mg/m^2 daunorubicin (or equivalent drug equivalent dose level).
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
- Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by NYHA Criteria (Class Ш or Ⅳ staging).
- Active or uncontrolled infection.
- Current evidence of invasive fungal infection (blood or tissue culture).
- Patients with known HIV, hepatitis B or hepatitis C infection.
- Patients who are hypersensitive to cytarabine, daunorubicin or liposomal products.
- Patients with a history of Wilson's disease or other copper-metabolism disorders.
- Participation in another clinical trial or treatment with any investigational drug within 28 days prior to screening.
- Any patients whom the investigator believes will not be a good candidate for the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (liposomal cytarabine-daunorubicin for injection)
Patients are eligible to receive up to 2 inductions and up to 2 consolidations with liposomal cytarabine-daunorubicin for injection.
The number of inductions and consolidations a patient received will depend on response.
|
First induction: 100 units/m^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m^2 by 90-minute IV infusion on Days 1 and 3.
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Experimental: Arm B (7+3)
Patients are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7+3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy.
The number of inductions and consolidations a subject received will depend on response.
|
First induction: 7+3 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1, 2, and 3. Second induction: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2. Consolidation therapy: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to 2 years
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Overall survival will be measured from the date of randomization to death from any cause.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival (EFS)
Time Frame: Up to 2 years
|
EFS is defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from complete remission (CR) or complete remission with incomplete count recovery (CRi) or death from any cause, whichever occurs first.
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Up to 2 years
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Duration of remission (DoR)
Time Frame: Up to 2 years
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DoR is defined as the time from the day achieving CR or CRi to the date of relapse or death.
Only patients achieving CR or CRi will be assessed for remission duration.
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Up to 2 years
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CR rate
Time Frame: Up to 2 years
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Proportion of patients with complete remission during the treatment period.
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Up to 2 years
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Composite remission rate
Time Frame: Up to 2 years
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Proportion of patients with CR or CRi.
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Up to 2 years
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Proportion of patients receiving a haematopoietic stem cell transplant (HSCT)
Time Frame: Up to 2 years
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The number and percentage of patient transferred for HSCT after induction treatment will be recorded.
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Up to 2 years
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Proportion of pateints who achieve CR with MRD negativity
Time Frame: Up to 2 years
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The number and percentage of patients who are MRD negative.
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Up to 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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
- Neoplastic Processes
- 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
- HC1702-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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