- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066242
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
September 27, 2023 updated by: weihui, Institute of Hematology & Blood Diseases Hospital, China
Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined.
Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (Ven+AZA vs DA/IA 3+7 vs DA/IA 2+5+VEN).
A total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group.
Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy.
Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity.
After completion of the treatment phase, patients entered the follow-up period.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui Wei, MD
- Phone Number: 86-022-23909020
- Email: weihui@ihcams.ac.cn
Study Locations
-
-
-
Tianjin, China
- Institute of Hematology & Blood Diseases Hospital
-
Contact:
- Hui Wei, MD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Able to understand the study and voluntarily sign informed consent.
- Age: 60~75 years old, gender unlimited.
- Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
- Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
- Fit for intensive chemotherapy.
- The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound
Exclusion Criteria:
- Patients with acute promyelocytic leukemia
- Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
- Patients with BCR::ABL fusion gene
- Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
- Patients with concurrent malignant tumors requiring treatment
- Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AZA+VEN
Two courses of azacitidine combined with venetoclax as induction regimen
|
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
|
Experimental: DA/IA 3+7
Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen
|
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
|
Experimental: DA/IA 2+5+VEN
Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen
|
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival (EFS)
Time Frame: Up to approximately 2 years
|
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Time Frame: Up to approximately eight weeks
|
Proportion of patients with CR, CRh or CRi
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Up to approximately eight weeks
|
Minimal residual disease (MRD)-negative remission rates after induction
Time Frame: Up to approximately eight weeks
|
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative
|
Up to approximately eight weeks
|
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
Time Frame: Up to approximately 1 years
|
The proportion of patients with negative MRD results at any time during treatment
|
Up to approximately 1 years
|
Relapse-free Survival (RFS)
Time Frame: Up to approximately 2 years
|
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
|
Up to approximately 2 years
|
Overall survival (OS)
Time Frame: Up to approximately 2 years
|
It is defined as the time from the start of randomization to the death from any cause.
|
Up to approximately 2 years
|
30-day postinduction mortality
Time Frame: Up to approximately 30 days
|
It is defined as death from any cause within 30 days after the start of induction.
|
Up to approximately 30 days
|
60-day postinduction mortality
Time Frame: Up to approximately 60 days
|
It is defined as death from any cause within 60 days after the start of induction.
|
Up to approximately 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hui Wei, MD, Institute of Hematology & Blood Diseases Hospital, China
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 (Estimated)
October 10, 2023
Primary Completion (Estimated)
October 10, 2025
Study Completion (Estimated)
October 10, 2025
Study Registration Dates
First Submitted
September 27, 2023
First Submitted That Met QC Criteria
September 27, 2023
First Posted (Actual)
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2023059-EC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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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