Study of Selinexor Combined With Chidamide in Relapsed/Refractory Acute Leukemia (AML) Patients

NCT05951855 | Unknown Phase 2

• 1 other identifier: Selinexor+ Chidamide
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia (Relapsed/Refractory)

Keywords

relapsed/refractory; AML; selinexor and chidamide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ORR

  Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).

  28 days after study treatment

Secondary Outcomes (4)

• Duration of Response (DOR)

  2 years

• Event-free survival (EFS)

  Time from registration to event, max 3 years

• Overall Survival (OS)

  Time from registration to event, max 3 years

• Number of Adverse Events (AE)

  continuously from first administration of study drug untill 30 days after last study treatment. (approximately up to 1 year)

Study Arms (1)

Selinexor combined with chidamide

EXPERIMENTAL

R/R AML who are ineligible for intensive chemotherapy will receive selinexor in combination with chidamide, 28 days per cycle, Selinexor will be used as 40 or 60mg BIW for two weeks, and chidamide will be used as 10mg/d from day 1 to 28. Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant.

Drug: Selinexor; Drug: Chidamide

Interventions

Selinexor DRUG

Selinexor 60mg/day, weight≥70kg (40mg/day, weight\<70kg) orally on d1,4,8,11,

Also known as: X

Selinexor combined with chidamide

Chidamide DRUG

Chidamide 10mg/day, orally on day 1 to 28

Also known as: C

Selinexor combined with chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 75 years old.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of 2-3.
• Patients whose expecting survival time will be more than 3 months.
• One of the serious heart, lung, liver, kidney disease:
• Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \<= 50% or chronic stable angina;
• Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \<= 65% or Forced Expiratory Volume in 1 second (FEV1) \<= 65%;
• Moderate hepatic impairment with total bilirubin \> 1.5 to \<= 3.0 × Upper Limit of Normal (ULN);
• Creatinine clearance \>= 30 mL/min to \< 45 ml/min;
• Other comorbidities that the physician judges to be incompatible with intensive chemotherapy.
• Patients who had not received radiotherapy, chemotherapy, targeted therapy within one week before enrollment.
• 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.
• Patients who are suitable for intensive chemotherapy but refuse it.
• Patients who have known and voluntarily signed the informed consent (ICF).

You may not qualify if:

• History of any malignancies prior to study entry with exception noted in the protocol.
• Patients who had previously been treated with selinexor and/or chidamide.
• Patients with APL/AML M3, or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML.
• Absolute white blood cell count \>=100\*10\^9/L.
• Persistent toxicity due to previous chemotherapy or radiotherapy did not recover to 2 grade.
• Presence of CNS leukemia.
• 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.
• Ucontrolled active infection (including bacterial, fungal or viral infections) and bleeding from internal organs.
• Pregnant and lactating women.
• Participated in any other clinical trials within 3 months before signing the informed consent form.
• Patients who are unsuitable for this study judged by clinicians.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

selinexor; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huiying Qiu, Ph.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Huiying Qiu, Ph.D

CONTACT

13912792913; qiuhuiying@aliyun.com

Depei Wu, Ph.D

CONTACT

67781856; drwudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 19, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)