Blood Hospital
Tianjin, 300020, China
Location status: Recruiting
NCT Number: NCT06265545
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
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Interventional
Not applicable
Tianjin, 300020, China
Location status: Recruiting
It is recommended to routinely screen for chromosomal karyotype, FLT3/ITD, FLT3/TKD and IDH1 mutations before enrollment.According to the patient's condition and physical condition, evaluate whether there is a suitable new drug clinical trial to enroll, if there is, enter the Arm 7 (new drug clinical trial); If not, enter other arm of the clinical study.According to the results of gene mutation, patients with target gene mutations should enter the corresponding study cohort (Arm1, Arm2), and select the regimen of specific targeted drug composition. For patients without a target mutation, patients eligible for intensive chemotherapy who had not received Venetoclax in the last 3 months were randomized to the Daunorubicin/idarbicin/mitoxantrone combination cytarabine + Venetoclax(DAV) (Arm3) and the Hyperhardinine combination cytarabine + Venetoclax cohort (HAV) (Arm4). Patients who were intolerant to intense chemotherapy were enrolled in the Venetoclax combined with Azacitidine cohort (Arm5). For patients who have failed treatment with Venetoclax within the last 3 months, the Venetoclax-based regimen is not recommended again and the physician is advised to conduct an exploratory trial (Arm6). After CR form induction therapy, allogeneic hematopoietic stem cell transplantation should be selected as far as possible according to the patient's wishes. For patients who are unable or unwilling to undergo allogeneic hematopoietic stem cell transplantation, physicians may choose post-remission consolidation therapy based on experience.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
if the target gene mutations are positive, enter arm1 or arm2. other conditions, enter the chemotherapy arms (Arm3-6)
Time frame: Time from remission date of the first subject until remission date of the last subject.
Proportion of patients with combined responses (complete and partial responses)
Time frame: Treatment within 30 days and 60 days
Mortality of patients treated within 30 and 60 days
Time frame: the whole period of the trial, up to 730 days
Proportion of patients with complete response and MRD negative
Time frame: the whole period of the trial, up to 730 days
Used to evaluate all patients entering clinical trials
Time frame: the whole period of the trial, up to 730 days
It is only used to evaluate patients who have achieved CR
Time frame: the whole period of the trial, up to 730 days.
It is only used to evaluate patients who have achieved CR
Institute of Hematology & Blood Diseases Hospital, China
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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