AML (Acute Myeloid Leukemia)NCT07236931
Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells
A study testing the XAB regimen in people with AML (Acute Myeloid Leukemia), run by Donghua Zhang at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- the XAB regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 15 Jul 2026
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL/min to <45 mL/min (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.
- Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)
- Renal function must meet the following criterion: Creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
- No history of drug allergies within the protocol.
- Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.
- The participant understands and signs the informed consent form.
Who cannot join
- A definitive diagnosis of Acute Promyelocytic Leukemia (APL).
- Age <18 years or ≥75 years.
- The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.
- Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.
- Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.
- Patients who have other malignancies that require treatment.
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- A history of allergy to the study drugs.
- Female participants who are pregnant or breastfeeding.
- Human immunodeficiency virus (HIV) infection or syphilis infection.
- Active hepatitis that remains uncontrolled despite active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid [HBV DNA] or hepatitis C virus ribonucleic acid [HCV RNA]).
- Patients with persistent positivity for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 (excluding those who have transitioned from positive to negative).
- Conditions that the investigator considers may increase the risk to participants or interfere with the study results.
- Other conditions that the investigator deems the participant unsuitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- the XAB regimen
- 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.
the XAB regimenDrug
the XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | selinexor (X), azacitidine (A), and venetoclax (B) - the XAB regimen Receives: Drug: the XAB regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1，3，6，12，18，24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jan 2025
- Primary completion30 May 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donghua Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donghua Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236931
- Sponsor's protocol ID
- DHZ1962-B
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2025
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells
- ClinicalTrials.gov ID
- NCT07236931
- Acronym / sponsor ID
- DHZ1962-B
- Conditions
- AML (Acute Myeloid Leukemia)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Donghua ZhangUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 19 Nov 2025 (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.
This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: the XAB regimenselinexor (X), azacitidine (A), and venetoclax (B) - the XAB regimen |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL/min to <45 mL/min (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.
- Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)
- Renal function must meet the following criterion: Creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
- No history of drug allergies within the protocol.
- Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.
Key exclusion criteria (13 listed)
- A definitive diagnosis of Acute Promyelocytic Leukemia (APL).
- Age <18 years or ≥75 years.
- The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.
- Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.
- Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.
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 |
|---|---|---|
| the XAB regimenthe XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B) | Drug | Experimental group |
Primary outcome
Overall survival
Time frame: 1，3，6，12，18，24 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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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 the XAB regimen in people with AML (Acute Myeloid Leukemia), run by Donghua Zhang 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 13 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: finished, as of the sponsor's last update on 17 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 1，3，6，12，18，24 months after treatment). 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 17 Jul 2026.