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Trial Title:
Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
NCT ID:
NCT06265545
Condition:
AML
Refractory
Relapsed
Conditions: Official terms:
Leukemia, Myeloid, Acute
Venetoclax
Ivosidenib
Gilteritinib
Conditions: Keywords:
AML
Refractory
Relapsed
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ivosidenib,Venetoclax,gilteritinib,Selinexor
Description:
if the target gene mutations are positive, enter arm1 or arm2. other conditions, enter
the chemotherapy arms (Arm3-6)
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 4
Arm group label:
Arm 5
Arm group label:
Arm 6
Arm group label:
Arm 7
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia)
diagnosed by bone marrow cell morphology, immunology and genetics above are
classified according to the French-British-American Collaboration diagnostic
criteria (FAB criteria) and the World Health Organization diagnostic criteria
(WHO2016 criteria).
2. Meet criteria for refractory/recurrent AML (except APL). The recurrence was
morphological recurrence, excluding molecular recurrence. Except for simple
extramedullary leukemia.
3. Age and gender are not limited. 4. Informed consent must be signed before the
start of the study procedure, and the informed consent must be signed by the
patient himself or his immediate family if he is 18 years old and above; For
young patients under the age of 18, the legal guardian shall sign the informed
consent. Considering the patient's condition, if the patient's signature is not
conducive to the treatment of the condition, the informed consent shall be
signed by the legal guardian or the patient's immediate family.
Exclusion Criteria:
1. Concurrent malignant tumors of other organs (patients requiring treatment).
2. Participants considered unsuitable for inclusion by the researchers.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Blood Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
hui wei, MD
Phone:
86-13132507161
Email:
weihui@ihcams.ac.cn
Start date:
February 22, 2024
Completion date:
June 30, 2026
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/NCT06265545
