Leukemia, Myeloid, AcutePhase 1/2NCT05682755
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
A Phase 1/2 study testing Chidamide in people with Leukemia, Myeloid, Acute, run by Sichuan University at 1 site in China.
Trial summary
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2022to 31 Dec 2026
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
- KPS score > 60 or ECOG score 0-2;
- The expected survival period > 3 months;
- Received allo-HSCT and achieved complete remission (CR);
- Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;
- No central nervous system involvement or clinical symptoms after transplantation;
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- Those who have no serious functional damage to important organs of the body;
- Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
- Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
Who cannot join
- Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
- Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
- Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
- Poor graft function (PGF) occurred after allo-HSCT;
- Combined with other malignant tumors and require treatment;
- Active GVHD;
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- Have a history of allergy to Chidamide;
- Pregnant or lactating females;
- Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
- Patients with active chronic hepatitis B or active hepatitis C;
- History of prolonged QT syndrome;
- Patients considered by other researchers to be unsuitable for this study.
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
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Jie Ji, MD, 86-28-85422370, jieji@scu.edu.cn
About this study
Official title: Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
- The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.
Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Chidamide
- 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.
ChidamideDrug
initial time：platelet count ≥50×10^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10^9/L-increased by 5 mg 20×10^9/L≤ platelet count <50×10^9/L-remains unchanged platelet count <50×10^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT
| Study group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Not described Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Measured: 2 years
Secondary outcomes (6)
100 day adverse events (AE)
non-hematologic adverse events
Measured: Day +100
Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 month
Measured: 6 months
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Measured: 2 years
Relapse rate
Relapse rate of this group of patients at the end of 2 year
Measured: 2 years
Cumulative incidence of acute graft versus host disease (aGVHD)
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Measured: Day +100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start22 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Sichuan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682755
- Sponsor's protocol ID
- PTChi 1.0
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Release after the publication of results of this trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study
- ClinicalTrials.gov ID
- NCT05682755
- Acronym / sponsor ID
- PTChi 1.0
- Conditions
- Leukemia, Myeloid, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 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 goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
- The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.
Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide | Experimental | Drug: Chidamide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
- KPS score > 60 or ECOG score 0-2;
- The expected survival period > 3 months;
- Received allo-HSCT and achieved complete remission (CR);
- Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;
Key exclusion criteria (12 listed)
- Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
- Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
- Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
- Poor graft function (PGF) occurred after allo-HSCT;
- Combined with other malignant tumors and require treatment;
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 |
|---|---|---|
| Chidamideinitial time：platelet count ≥50×10^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10^9/L-increased by 5 mg 20×10^9/L≤ platelet count <50×10^9/L-remains unchanged platelet count <50×10^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT | Drug | Chidamide |
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
Progression free survival of this group of patients at the end of 2 year
6 secondary outcomes
100 day adverse events (AE)
Time frame: Day +100
Non-relapse mortality (NRM)
Time frame: 6 months
Overall survival (OS)
Time frame: 2 years
Relapse rate
Time frame: 2 years
Cumulative incidence of acute graft versus host disease (aGVHD)
Time frame: Day +100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Time frame: 2 years
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 12 Jan 2023.
- Individual participant dataSharing planned: Yes. Release after the publication of results of this trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chidamide in people with Leukemia, Myeloid, Acute, run by Sichuan 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 2 years). 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 12 Jan 2023.