Acute Myeloid LeukemiaPhase 3NCT06613035
Twice-per-weekSelinexor, 2 Days Melphalan
A Phase 3 study testing Selinexor, Melphalan and Intravenous Busulfan in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites in China.
Trial summary
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Selinexor, Melphalan and Intravenous Busulfan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesChina
- Study dates
- 30 Sep 2024to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia).
- 2. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation).
- 3. Age ≥ 55 years. 4. Disease status prior to allogeneic transplantation must be complete remission (CRc), confirmed by bone marrow analysis within three days prior to randomization.
- 5. Karnofsky Performance Score (KPS) of at least 60. 6. Informed consent must be signed prior to the commencement of the study procedures. If the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient.
- Note: High-risk AML: ① Patients classified as high-risk according to the ELN 2022 grading criteria. ② AML patients with persistent MRD positivity prior to transplantation. ③ Patients with refractory or relapsed AML.
Who cannot join
- 1. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:
- History of uncontrolled or symptomatic angina.
- Myocardial infarction within the last 6 months prior to study enrollment.
- History of arrhythmias requiring medication or with clinically significant symptoms.
- Uncontrolled or symptomatic congestive heart failure (NYHA class > 2).
- Ejection fraction below the lower limit of the normal range. 3. Respiratory failure (PaO2 ≤ 60 mmHg). 4. Liver dysfunction (total bilirubin ≥ 3 mg/dL, transaminases > twice the upper limit of normal).
- 5. Renal dysfunction (creatinine clearance rate < 30 mL/min). 6. Presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements.
- 7. ECOG performance status of ≥ 4. 8. Uncontrolled or active infection. 9. Any condition that impairs the ability to provide informed consent. 10. Any conditions deemed unsuitable for enrollment by the investigator prior to randomization.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, 610083
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong
Hebei Medical University Second Hospital
Shijiazhuang, Hebeisheng, 05000
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, 450000
About this study
Official title: Twice-per-week Selinexor, 2 Days Melphalan Plus BU2FLU3 Compared with BU3FLU5 for Elder High-risk Acute Myeloid Leukemia Undergoing Allogenic Hematopoietic Cell Transplantation: a Multi-center Randomized Phase 3 Trial
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial
Read the detailed description
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.
Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Selinexor, Melphalan, Intravenous Busulfan, Fludarabine
- Keywords
- allogeneic hematopoietic stem cell transplantation
- 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 from days -9 to -5.
MelphalanDrug
Selinexor: 60 mg/day from days -9 to -5.
Intravenous BusulfanDrug
3.2 mg/kg on days
FludarabineDrug
30 mg/m² on days
| Study group | Role | What they receive |
|---|---|---|
| SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen | Experimental | * Selinexor: 60 mg/day from days -9 to -5.
* Melphalan: 60 mg/m² on days -8 and -7.
* Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5.
* Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2. Receives: Drug: Selinexor; Drug: Melphalan; Drug: Intravenous Busulfan; Drug: Fludarabine |
| Patients in the BF group will receive the BU3FLU5 conditioning regimen | Experimental | * Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7.
* Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2. Receives: Drug: Intravenous Busulfan; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year RFS
The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.
Measured: 1-year
Secondary outcomes (2)
1-year OS
1-year OS
Measured: 1-year
1-year GVHD
1-year GVHD
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613035
- Sponsor's protocol ID
- IIT2024062
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twice-per-week Selinexor, 2 Days Melphalan Plus BU2FLU3 Compared with BU3FLU5 for Elder High-risk Acute Myeloid Leukemia Undergoing Allogenic Hematopoietic Cell Transplantation: a Multi-center Randomized Phase 3 Trial
- ClinicalTrials.gov ID
- NCT06613035
- Acronym / sponsor ID
- IIT2024062
- Conditions
- Acute Myeloid Leukemia
- Keywords
- allogeneic hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Sep 2024 (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.
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial
Detailed description
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.
Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen | Experimental | Drug: Selinexor, Drug: Melphalan, Drug: Intravenous Busulfan, Drug: Fludarabine* Selinexor: 60 mg/day from days -9 to -5. * Melphalan: 60 mg/m² on days -8 and -7. * Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5. * Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2. |
| Patients in the BF group will receive the BU3FLU5 conditioning regimen | Experimental | Drug: Intravenous Busulfan, Drug: Fludarabine* Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7. * Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia).
- 2. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation).
- 3. Age ≥ 55 years. 4. Disease status prior to allogeneic transplantation must be complete remission (CRc), confirmed by bone marrow analysis within three days prior to randomization.
- 5. Karnofsky Performance Score (KPS) of at least 60. 6. Informed consent must be signed prior to the commencement of the study procedures. If the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient.
- Note: High-risk AML: ① Patients classified as high-risk according to the ELN 2022 grading criteria. ② AML patients with persistent MRD positivity prior to transplantation. ③ Patients with refractory or relapsed AML.
Key exclusion criteria (8 listed)
- 1. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:
- 5. Renal dysfunction (creatinine clearance rate < 30 mL/min). 6. Presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements.
- 7. ECOG performance status of ≥ 4. 8. Uncontrolled or active infection. 9. Any condition that impairs the ability to provide informed consent. 10. Any conditions deemed unsuitable for enrollment by the investigator prior to randomization.
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 from days -9 to -5. | Drug | SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen |
| MelphalanSelinexor: 60 mg/day from days -9 to -5. | Drug | SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen |
| Intravenous Busulfan3.2 mg/kg on days | Drug | Patients in the BF group will receive the BU3FLU5 conditioning regimen, SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen |
| Fludarabine30 mg/m² on days | Drug | Patients in the BF group will receive the BU3FLU5 conditioning regimen, SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen |
Primary outcome
1-year RFS
Time frame: 1-year
The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.
2 secondary outcomes
1-year OS
Time frame: 1-year
1-year GVHD
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selinexor, Melphalan and Intravenous Busulfan in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang (15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year RFS (time frame: 1-year). 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 25 Sep 2024.