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Trial Title:
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
NCT ID:
NCT06066242
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
elderly
newly diagnosed
fit
induction regimen
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Different induction chemotherapy regimens
Description:
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
Arm group label:
AZA+VEN
Arm group label:
DA/IA 2+5+VEN
Arm group label:
DA/IA 3+7
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to understand the study and voluntarily sign informed consent.
2. Age: 60~75 years old, gender unlimited.
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
5. Fit for intensive chemotherapy.
6. 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:
1. Patients with acute promyelocytic leukemia
2. Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
3. Patients with BCR::ABL fusion gene
4. Patients who have received a prior treatment for AML with chemotherapy,
hypomethylating agents or venetoclax before.
5. Patients with concurrent malignant tumors requiring treatment
6. 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.
7. Uncontrolled active serious infections that could, in the investigator's opinion,
potentially interfere with the completion of treatment
Gender:
All
Minimum age:
60 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wei, MD
Start date:
October 1, 2023
Completion date:
October 10, 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06066242
