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Acute Myeloid Leukemia (Relapsed/Refractory)Phase 2NCT05951855

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

A Phase 2 study testing Selinexor and Chidamide in people with Acute Myeloid Leukemia (Relapsed/Refractory), run by The First Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Selinexor and Chidamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
1 Mar 2023to 1 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Huiying Qiu, Ph.D contact

13912792913

qiuhuiying@aliyun.com

Depei Wu, Ph.D contact

67781856

drwudepei@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Huiying Qiu, Ph.D, 13912792913, qiuhuiying@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Selinexor in Combination With Chidamide in Unfit Relapsed/Refractory Acute Leukemia: a Phase 2, Single-Arm, Open-Label, Multi-Center Prospective Study.

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.

Read the 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.

Being tested
Selinexor, Chidamide
Keywords
relapsed/refractory, AML, selinexor and chidamide
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called X

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

  • ChidamideDrug

    Also called C

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

Study groups in NCT05951855
Study groupRoleWhat they receive
Selinexor combined with chidamideExperimentalR/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.
Receives: Drug: Selinexor; Drug: Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 28 days after study treatment

Secondary outcomes (4)

  1. Duration of Response (DOR)

    Defined as time, in months, from initial response (CR+CRi+PR+MLFS) until the date of a disease progression

    Measured: 2 years

  2. Event-free survival (EFS)

    Defined as the number of days from the date of treatment initiation (i.e., course 1 day 1) to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first. Will be calculated for all patients. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.

    Measured: Time from registration to event, max 3 years

  3. Overall Survival (OS)

    Calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.

    Measured: Time from registration to event, max 3 years

  4. Number of Adverse Events (AE)

    Adverse events are evaluated with CTCAE V5.0.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951855
Sponsor's protocol ID
Selinexor+ Chidamide
Status last verified
Aug 2022
First submitted
24 Jun 2023
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor and Chidamide in people with Acute Myeloid Leukemia (Relapsed/Refractory), run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huiying Qiu, Ph.D (13912792913, qiuhuiying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With ORR (time frame: 28 days after study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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