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| Name | Class |
|---|---|
| Antengene Corporation | INDUSTRY |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor、HAD or CAG regimens | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission Rate | complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate) | max 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | max 2 years |
| Treatment-Related Mortality (TRM) |
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Inclusion Criteria:
Exclusion Criteria:
Early withdrawal from test criteria:
Participants have the right to withdraw from the study at any time from the trial. Exit Criteria:
Doctor/Investigator required subjects to terminate the trial early:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Wang | Contact | 13835175119 | wangtao99699@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Wang | Shanxi Bethune Hospital Regulatory Authority | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tao Wang | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2022 | Feb 8, 2023 |
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| Homoharringtonine | Drug | Given per standard of care |
|
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| Daunorubicin | Drug | Given per standard of care |
|
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| Cytarabine | Drug | Given per standard of care |
|
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| Granulocyte Colony-Stimulating Factor | Drug | Given per standard of care |
|
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| Aclacinomycin | Drug | Given per standard of care |
|
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A death that is considered to be causally linked to a treatment
| 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 | 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. | 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. | max 2 years |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C585161 | selinexor |
| D000077863 | Homoharringtonine |
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C011157 | aclacinomycins |
| ID | Term |
|---|---|
| D006248 | Harringtonines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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