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Trial Title:
Study of Selinexor Combined With Chidamide in Relapsed/Refractory Acute Leukemia (AML) Patients
NCT ID:
NCT05951855
Condition:
Acute Myeloid Leukemia (Relapsed/Refractory)
Conditions: Official terms:
Leukemia
Conditions: Keywords:
relapsed/refractory
AML
selinexor and chidamide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
Selinexor 60mg/day, weight≥70kg (40mg/day, weight<70kg) orally on d1,4,8,11,
Arm group label:
Selinexor combined with chidamide
Other name:
X
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Chidamide 10mg/day, orally on day 1 to 28
Arm group label:
Selinexor combined with chidamide
Other name:
C
Summary:
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy
and safety of selinexor combined with chidamide in the treatment of unfit R/R AML.
Detailed description:
This protocol corresponds to a multicenter, open-label, single arm, prospective study
designed to determine the efficacy and safety of selinexor in combination with chidamide
for unfit R/R AML.
Selinexor will be given orally at 40 or 60mg on d1,4,8,11; Chidamide will be given orally
at 10mg on d1-28; 28 days per cycle. patients can receive transplants at any time once
they achieved complete remission and other patients will continue to receive treatment
until disease progression or unacceptable toxic effects. After completion of study
treatment, participants are followed up every 3 to 6 months for up to 2 years.
Study design allows 42 patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men and women aged 18 to 75 years old.
2. Diagnosis of relapsed or refractory AML (defined according to the the World Health
Organization [WHO] 2016 criteria) of any type except for acute promyelocytic
leukemia (APL; AML M3).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 2-3.
4. Patients whose expecting survival time will be more than 3 months.
5. One of the serious heart, lung, liver, kidney disease:
1. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or
Ejection Fraction <= 50% or chronic stable angina;
2. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced
Expiratory Volume in 1 second (FEV1) <= 65%;
3. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit
of Normal (ULN);
4. Creatinine clearance >= 30 mL/min to < 45 ml/min;
6. Other comorbidities that the physician judges to be incompatible with intensive
chemotherapy.
7. Patients who had not received radiotherapy, chemotherapy, targeted therapy within
one week before enrollment.
8. Fertile women and men whose partner is of childbearing potential or pregnant should
agree to practice complete abstinence or to use a condom during therapy and dose
interruptions and for 90 days after the last treatment.
9. Patients who are suitable for intensive chemotherapy but refuse it.
10. Patients who have known and voluntarily signed the informed consent (ICF).
Exclusion Criteria:
1. History of any malignancies prior to study entry with exception noted in the
protocol.
2. Patients who had previously been treated with selinexor and/or chidamide.
3. Patients with APL/AML M3, or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML.
4. Absolute white blood cell count >=100*10^9/L.
5. Persistent toxicity due to previous chemotherapy or radiotherapy did not recover to
2 grade.
6. Presence of CNS leukemia.
7. Patients who had undergone cardiac angioplasty or stent implantation within 12
months before signing the informed consent form, or had myocardial infarction or
instability history of defined angina or other clinically significant cardiac
events.
8. Ucontrolled active infection (including bacterial, fungal or viral infections) and
bleeding from internal organs.
9. Pregnant and lactating women.
10. Participated in any other clinical trials within 3 months before signing the
informed consent form.
11. Patients who are unsuitable for this study judged by clinicians.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiying Qiu, Ph.D
Phone:
13912792913
Email:
qiuhuiying@aliyun.com
Start date:
March 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05951855
