Relapsed/Refractory AMLNCT05805072
Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients
A study testing Selinexor, Homoharringtonine and Cytarabine in people with Relapsed/Refractory AML, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory AML
- What is being tested?
- Selinexor, Homoharringtonine and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥18 years.
- Diagnosis of AML (defined according to the 5th of the World Health Organization [WHO] 2022 criteria) of any type except for acute promyelocytic leukemia (APL; AML M3)and the following conditions were met: Relapsing or refractory AML
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication.
- Patients whose expecting survival time will be more than 3 months.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Who cannot join
- AML transformed from chronic myeloid leukemia.
- Patients with APL/AML M3.
- Presence of CNS leukemia.
- Uncontrolled infection or other serious disease.
- Unstable cardiovascular function: Cardiac ejection fraction (EF)<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2.
- Unstable Liver and kidney function:TBLL≥2.0 mg/dl, AST≥3×ULN, Ccr≥50 ml/min, SpO2<92%.
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- Known human immunodeficiency virus (HIV) infection.
- Active hepatitis B or hepatitis C infection.
- Pregnant and lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: An Open Label, Single Arm, Single-Center Exploratory Study to Evaluate the Efficacy and Safety of Selinexor and HAAG +/- HMA in Relapsed/Refractory Acute Leukemia (AML) Patients
The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.
Read the detailed description
This protocol corresponds to a single-center, open-label, single-arm, exploratory study designed to determine the efficacy and safety of the combination of selinexor with HAAG +/- HMA in patients with relapsed or refractory AML. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment according to patient's wishes.
Each cycle of treatment will compromise 2 weeks of selinexor treatment, and at least two weeks off treatment. The new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving CR.
Study design allows 20 patients. Treatment will consist of selinexor 60 mg/day orally on d1,4,8,11, HHT 1 mg/day intravenously on days 3 to 9, cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9, aclacinomycin 10 mg/day intravenously on days 3 to 6, G-CSF 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, DAC 20 mg/m2/day intravenously on days 1 to 5. Whether to add hypomethylating agents was decided by the investigator according to the patient's disease degree and tolerance status. If patients had previously been exposed to decitabine, azacitidine will added this regimen, AZA 20 mg/m2/day subcutaneously on days 1 to 7.
- Conditions
- Relapsed/Refractory AML
- Being tested
- Selinexor, Homoharringtonine, Cytarabine, Aclacinomycin, Granulocyte Colony-Stimulating Factor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Selinexor 60 mg/day, orally on d1,4,8,11
HomoharringtonineDrug
Homoharringtonine 1 mg/day intravenously on days 3 to 9
CytarabineDrug
cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9
AclacinomycinDrug
aclacinomycin 10 mg/day intravenously on days 3 to 6
Granulocyte Colony-Stimulating FactorDrug
granulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram,
DecitabineDrug
Decitabine 20 mg/m2/day intravenously on days 1 to 5.
AzacitidineDrug
Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7
| Study group | Role | What they receive |
|---|---|---|
| Selinexor+HAAG±HMA | Experimental | Not described Receives: Drug: Selinexor; Drug: Homoharringtonine; Drug: Cytarabine; Drug: Aclacinomycin; Drug: Granulocyte Colony-Stimulating Factor; Drug: Decitabine; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With CR/CRi
Number of Participants With CR/CRi
CR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease.
CRi: Same as CR, but ANC may be <1.0x10^9/L and/or Platelet count <100x10^9/L
Measured: End of cycle 1 and 2 (each cycle is 28 days)
Secondary outcomes (5)
Number of Participants With ORR
ORR =CR+CRi+PR+MLFS
PR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.
MLFS: Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease
Measured: End of cycle 1 and 2 (each cycle is 28 days)
Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation)
Rate of ASCT: Percentage of patients being transplanted after induction therapy (stem cell transplantation)
Measured: 1-2 induction cycles (4 - 8 weeks)
Progression-Free Survival
Progression-free survival (PFS): was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.
Disease progression was defined as presence of >50% increase in bone marrow blasts to a level of at least 50% and/or a doubling of the percentage of peripheral blood blasts to a level of at least 50%.
Measured: Time from registration to event, max 2 years
Overall Survival
Overall survival (OS) was 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.
Measured: Time from registration to event, max 2 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0
Measured: End of cycle 1 and 2 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory AMLStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805072
- Sponsor's protocol ID
- Selinexor+HAAG+HMA
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Single-Center Exploratory Study to Evaluate the Efficacy and Safety of Selinexor and HAAG +/- HMA in Relapsed/Refractory Acute Leukemia (AML) Patients
- ClinicalTrials.gov ID
- NCT05805072
- Acronym / sponsor ID
- Selinexor+HAAG+HMA
- Conditions
- Relapsed/Refractory AML
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.
Detailed description
This protocol corresponds to a single-center, open-label, single-arm, exploratory study designed to determine the efficacy and safety of the combination of selinexor with HAAG +/- HMA in patients with relapsed or refractory AML. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment according to patient's wishes.
Each cycle of treatment will compromise 2 weeks of selinexor treatment, and at least two weeks off treatment. The new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving CR.
Study design allows 20 patients. Treatment will consist of selinexor 60 mg/day orally on d1,4,8,11, HHT 1 mg/day intravenously on days 3 to 9, cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9, aclacinomycin 10 mg/day intravenously on days 3 to 6, G-CSF 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, DAC 20 mg/m2/day intravenously on days 1 to 5. Whether to add hypomethylating agents was decided by the investigator according to the patient's disease degree and tolerance status. If patients had previously been exposed to decitabine, azacitidine will added this regimen, AZA 20 mg/m2/day subcutaneously on days 1 to 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor+HAAG±HMA | Experimental | Drug: Selinexor, Drug: Homoharringtonine, Drug: Cytarabine, Drug: Aclacinomycin, Drug: Granulocyte Colony-Stimulating Factor, Drug: Decitabine, Drug: Azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged ≥18 years.
- Diagnosis of AML (defined according to the 5th of the World Health Organization [WHO] 2022 criteria) of any type except for acute promyelocytic leukemia (APL; AML M3)and the following conditions were met: Relapsing or refractory AML
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication.
- Patients whose expecting survival time will be more than 3 months.
Key exclusion criteria (9 listed)
- AML transformed from chronic myeloid leukemia.
- Patients with APL/AML M3.
- Presence of CNS leukemia.
- Uncontrolled infection or other serious disease.
- Unstable cardiovascular function: Cardiac ejection fraction (EF)<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorSelinexor 60 mg/day, orally on d1,4,8,11 | Drug | Selinexor+HAAG±HMA |
| HomoharringtonineHomoharringtonine 1 mg/day intravenously on days 3 to 9 | Drug | Selinexor+HAAG±HMA |
| Cytarabinecytarabine 10 mg/m2 q12h, intravenously on days 3 to 9 | Drug | Selinexor+HAAG±HMA |
| Aclacinomycinaclacinomycin 10 mg/day intravenously on days 3 to 6 | Drug | Selinexor+HAAG±HMA |
| Granulocyte Colony-Stimulating Factorgranulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, | Drug | Selinexor+HAAG±HMA |
| DecitabineDecitabine 20 mg/m2/day intravenously on days 1 to 5. | Drug | Selinexor+HAAG±HMA |
| AzacitidineAzacitidine 20 mg/m2/day subcutaneously on days 1 to 7 | Drug | Selinexor+HAAG±HMA |
Primary outcome
Number of Participants With CR/CRi
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
Number of Participants With CR/CRi CR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease. CRi: Same as CR, but ANC may be <1.0x10^9/L and/or Platelet count <100x10^9/L
5 secondary outcomes
Number of Participants With ORR
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation)
Time frame: 1-2 induction cycles (4 - 8 weeks)
Progression-Free Survival
Time frame: Time from registration to event, max 2 years
Overall Survival
Time frame: Time from registration to event, max 2 years
Number of adverse events
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selinexor, Homoharringtonine and Cytarabine in people with Relapsed/Refractory AML, 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 6 inclusion and 9 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 6 May 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With CR/CRi (time frame: End of cycle 1 and 2 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.