To hear about similar clinical trials, please enter your email below
Trial Title:
Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy
NCT ID:
NCT06449482
Condition:
Acute Myeloid Leukemia, Adult
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
selinexor venetoclax and azacitidine
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
three dosage groups were set up, selinexor 60mg QW, 40mg BIW, or 60mg BIW
Arm group label:
selinexor venetoclax Azacitidine
Other name:
XPO1-i
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
cycle 1 100mg d1 200mg d2 400mg d3-28 cycle 2-4 400mg d1-d28
Arm group label:
selinexor venetoclax Azacitidine
Other name:
BCL-2i
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
75mg/m2 d1-d7 28d/cycle 4 cycles
Arm group label:
selinexor venetoclax Azacitidine
Summary:
This study is a single arm open exploratory clinical trial to evaluate the efficacy and
safety of selinexor combined with venetoclax and azacitidine. This study will be divided
into two stages: dose increasing stage and dose expanding stage. In the dose-increasing
stage, the study induction therapy was designed using a 3+3 design. The induction therapy
and consolidation therapy of the subjects will be administered at RP2D doses.
During this study period, there were a total of 4 cycles. The treatment cycle of the
subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation
therapy.
In addition, if the subject does not achieve remission (CR/Cr or PR) after 2 cycles of
consolidation treatment (at the end of the 4th course), the study will be terminated by
the subject, and the clinical doctor will choose the subsequent treatment for the subject
based on clinical experience.
Detailed description:
This study is a single arm open exploratory clinical trial to evaluate the efficacy and
safety of selinexor combined with venetoclax and azacitidine. This study will be divided
into two stages: dose increasing stage and dose expanding stage. In the dose-increasing
stage, the study induction therapy was designed using a 3+3 design. In this stage, three
dosage groups were set up, namely selinexor 60mg QW, 40mg BIW, or 60mg BIW, in
combination with venetoclax 100mg d1 200mg d2 400mg d3-28, orally once a day, and
azacitidine 75mg/m2, d1-7, subcutaneously. The regimen was repeated every 28 days. In
this case, RP2D is determined based on MTD, safety, and all other data.
The methods of venetoclax and azacitidine remain unchanged during consolidation therapy.
Before RP2D is determined, the dosage of selinexor is determined by the researchers based
on individual subject tolerance. After RP2D is determined, the study enters the second
stage of dose expansion. The induction therapy and consolidation therapy of the subjects
will be administered at RP2D doses.
During this study period, there were a total of 4 cycles. The treatment cycle of the
subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation
therapy. In addition, if the subject does not achieve remission (CR/Cr or PR) after 2
cycles of consolidation treatment (at the end of the 4th course), the study will be
terminated by the subject, and the clinical doctor will choose the subsequent treatment
for the subject based on clinical experience.
The subjects will participate in the screening period, treatment period, and follow-up
period. The screening period lasts for a maximum of 28 days before medication. The
treatment period lasts from the first day of the first cycle to the end of the study
treatment. The follow-up period starts after the end of treatment and lasts for at least
12 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed AML patients diagnosed according to WHO standards who are not
suitable for the standard induction treatment regimen of cytarabine combined with
anthracycline drugs due to age or comorbidities.
2. Age ≥ 75 years old, ECOG score 0-2 points; The patient's age range is 18-75 years
old, with an ECOG score of 0-3.
3. Liver function meets the following criteria: total bilirubin<3 × Upper limit of
normal range (ULN) (<75 years old), total bilirubin<1.5 × ULN (≥ 75 years old),
AST<3 × ULN and ALT<3 × ULN.
4. Renal function meets the following criteria: creatinine clearance rate ≥ 30 mL/min
(Cockroft-Gault formula).
5. Expected survival time greater than 6 months
Exclusion Criteria:
1. patient who has received BCL2 inhibitors, demethylation drugs, chemotherapy, CAR-T
therapy, or other experimental therapies.
2. History of myeloproliferative tumors (MPN).
3. Cytogenetic low risk, such as t (8; 21), inv (16), t (16; 16) or t (15; 17).
4. Acute promyelocytic leukemia.
5. AML central nervous system (CNS) involvement.
6. Pregnancy or lactation period.
7. I underwent major surgery within 4 weeks before the first study medication.
8. Subjects with unstable or active cardiovascular diseases who meet any of the
following criteria:
9. Symptomatic myocardial ischemia;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
hui wei, Dr
Phone:
13132507161
Email:
weihui@ihcams.ac.cn
Start date:
May 5, 2023
Completion date:
April 30, 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/NCT06449482
