Relapsed or Refractory Acute Myeloid LeukemiaPhase 3NCT05726110
Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 3 study testing Selinexor, Homoharringtonine and Daunorubicin in people with Relapsed or Refractory Acute Myeloid Leukemia, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia
- What is being tested?
- Selinexor, Homoharringtonine and Daunorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2023to 31 Dec 2024
- Phase
- Phase 3
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:18-60 years old;
- Except for patients with AML-M3 with acute myeloid leukemia；
- Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission after 2 courses of induction chemotherapy;(2) Relapse within 6 months after the first complete remission; (3) Patients who relapse after 6 months after the first complete remission, and those who fail to induce chemotherapy after the original program; (4) 2 or more recurrences; (5) Extramedullary leukemia persists；
- Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) >5% of bone marrow naive cells; (3) Extramedullary recurrence；
- The bone marrow image indicates active hyperplasia or hypoproliferation；
- Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2.
Who cannot join
- Accompanied by cerebral hemorrhage；
- Pregnancy；
- Have a mental illness or other condition that cannot proceed as planned；
- Severe arrhythmia, abnormal ECG (QT>500ms).
- Early withdrawal from test criteria：
- Participants have the right to withdraw from the study at any time from the trial. Exit Criteria:
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- The subject or the subject's legally authorized representative requests to withdraw from the study;
- Participant loss to follow-up.
- Doctor/Investigator required subjects to terminate the trial early:
- Subjects who are unable to carry out follow-up treatment due to adverse events (serious irreversible organ function damage during treatment) who are judged by the investigator to be unsuitable for continuing the research;
- The subject does not adhere to the protocol, such as the use of chemotherapy drugs, etc., which affects the effectiveness and safety judgment.
- For participants who withdrew early from the study (except subjects who were lost to follow-up), the reason for their early withdrawal should be recorded, and the time of the last study's medication/treatment should be recorded, and the examination items at the time of early withdrawal from the study should be completed at the last visit, if possible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tao Wang
Taiyuan, Shanxi, 030000
Tao Wang, doctorial, 13835175119, wangtao99699@163.com
About this study
Official title: A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
Read the detailed description
Main Purpose：
To observe the efficacy of selinexor in combination with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia :complete remission rate (CR rate), partial remission rate (PR rate), no remission rate (NR rate), complete remission with incomplete hematologic recovery(CRi rate)
Secondary Purposes：
- To observe the recurrence rate of selinexor combined with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia, treatment-related mortality(TRM), Overall Survival (OS), Event-Free Survival (EFS);
- Safety indicators: to observe adverse events and deaths during treatment with selinexor in combination with HAD or CAG regimen.
- Being tested
- Selinexor, Homoharringtonine, Daunorubicin, Cytarabine, Granulocyte Colony-Stimulating Factor
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called KPT-330
Given PO
HomoharringtonineDrug
Also called HHT
Given per standard of care
DaunorubicinDrug
Also called DNR
Given per standard of care
CytarabineDrug
Also called Ara-C
Given per standard of care
Granulocyte Colony-Stimulating FactorDrug
Also called G-CSF
Given per standard of care
AclacinomycinDrug
Also called ACM
Given per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Selinexor、HAD or CAG regimens | Experimental | * Selinexor (60 mg) is used twice weekly for two weeks (four times, 240 mg total of selinexor) in combination with HAD or CAG regimens for reinduction therapy in patients with relapsed and refractory AML.
* (Bone marrow image indicates active hyperplasia) HAD regimen: homoharringtonine (HHT) (2mg/ m^2/d)×7days, daunorubicin (DNR, 40mg/ m^2/d)×3 days, cytarabine (Ara-C,100-200mg/ m^2/d)×7 days (no leukocyte drugs should be used throughout the treatment process)；
* (Bone marrow image indicates hypoproliferation)CAG regimen: Granulocyte Colony-Stimulating Factor (G-CSF, 5ug/kg/d, started 12 hours before chemotherapy×14 days (d1-d14), aclacinomycin (20mg/d)×4 days (d1-4), cytarabine (10 mg/ m^2, subcutaneous injection, 1 time in 12 hours)×14 days (d1-d14).
* G-CSF was discontinued in the CAG regimen when WBC > 20×10^9/L, but chemotherapy was not stopped. Receives: Drug: Selinexor; Drug: Homoharringtonine; Drug: Daunorubicin; Drug: Cytarabine; Drug: Granulocyte Colony-Stimulating Factor; Drug: Aclacinomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission Rate
complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate)
Measured: max 2 years
Secondary outcomes (5)
Recurrence Rate
After complete remission, (1) naive cells appear in peripheral blood; (2) >5% of bone marrow naive cells; (3) Extramedullary recurrence(refer to the 2014 NCCN guidelines).
Measured: max 2 years
Treatment-Related Mortality (TRM)
A death that is considered to be causally linked to a treatment
Measured: max 2 years
Overall Survival (OS)
Overall survival is a secondary endpoint that will be measured as time from the start of treatment until death from any cause, or the last date the patient was known to be alive
Measured: max 2 years
Event-Free Survival (EFS)
Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi.
Measured: max 2 years
Safety:Incidence and severity of adverse events
To evaluate the possible adverse events and deaths during treatment with selinexor in combination with HAD or CAG，mainly including liver toxicity, cardiotoxicity, bacterial infection, viral infection, fungal infection.
Measured: max 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start29 Jan 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Antengene Corporation
- Responsible party
- Sponsor
- Investigators
- Tao Wang, Study director, Shanxi Bethune Hospital Regulatory Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726110
- Sponsor's protocol ID
- ShanxiBethuneH
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No