Leukemia, AcutePhase 2NCT03336632
Chidamide Plus PTCy/Cyclosporine to Prevent GVHD After Myeloablative Conditioning, Matched PBSCT
A Phase 2 study testing Chidamide, Cyclophosphamide and cyclosporine A in people with Leukemia, Acute and MDS, run by Sichuan University at 2 sites in China.
Trial summary
This study is to explore the efficacy and safety of introduction of chidamide in PTCy based GVHD prophylaxis in patients undergoing allogeneic PBSCT. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Leukemia, Acute, MDS
- What is being tested?
- Chidamide, Cyclophosphamide and cyclosporine A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 30 Mar 2021
- Phase
- Phase 2
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years or older, and ≤ 65 years at time of enrollment
- Signed informed consent
- Hematologic disorder requiring allogeneic hematopoietic cell transplantation
- Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
- Transaminases (AST, ALT) < 3 times upper limit of normal (ULN) values
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- Creatinine clearance calculated ≥ 50 mL/min
- Karnofsky Performance Status Score ≥ 60%.
- Human leukocyte antigen (HLA) matched 8/ (A, B, C, DRB1) related or unrelated donor
Who cannot join
- Active infection not controlled with appropriate antimicrobial therapy HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are eligible), or hepatitis C infection
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) ≥4
- Anti-thymocyte globulin (ATG) as part of the conditioning regimen
- Pregnancy
- Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment of cancer within 30 days
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first chidamide treatment
- Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: Any history of ventricular fibrillation or torsade de pointes; Bradycardia defined as heart rate (HR)< 45 bpm (Patients with pacemakers are eligible if HR ≥ 45 bpm); Screening electrocardiogram (ECG) with a QTcF > 480 msec; Right bundle branch block + left anterior hemiblock (bifascicular block); Patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; Other clinically significant heart disease (e.g., New York Heart Association (NYHA) class III or IV , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on Appendix B of study documents that are required for hematopoietic cell transplantation (HCT) patients.
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
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 Plus Post-transplantation Cyclophosphamide and Cyclosporine to Prevent Graft-versus-host Disease After Myeloablative Conditioning, Matched Peripheral-blood Stem-cell Transplantation
This study is to explore the efficacy and safety of introduction of chidamide in PTCy based GVHD prophylaxis in patients undergoing allogeneic PBSCT.
Read the detailed description
Eligible patients were aged 16 to 65 years, diagnosed with hematologic malignancy, and had a Karnofsky performance score of ≥70% and were candidates for myeloablative HCT. A 8/8 HLA allelic match between the donor and the recipient at HLA-A, HLA-B, HLA-C, and HLA-DRB1 by high-resolution typing was required. The graft source was PBSC.
Patients received a myeloablative conditioning regimen consisting of oral chidamide given twice weekly at a dose of 20 mg from day -7 to 2 weeks post transplantation, intravenous busulfan 3.2 mg/kg from day -6 to -3, intravenous fludarabine 30 mg/m2 and cytarabine 1g/m2 respectively from day -6 to -2. PBSCs were infused on day 0. GVHD prophylaxis was post-transplantation cyclophosphamide (50 mg/kg on day +3, +4) and cyclosporine (started from day +5). In the absence of GVHD, cyclosporine tapering started on day +100 and discontinued on day +180. Minimal residual disease (MRD) was determined by multi-parameter flow cytometry.
- Conditions
- Leukemia, Acute, MDS
- Being tested
- Chidamide, Cyclophosphamide, cyclosporine A
- Keywords
- PBSCT, myeloablative conditioning, HDACi, chidamide
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called HBI-8000
20 mg orally, twice weekly from D-7 to D+14
CyclophosphamideDrug
50 mg/Kg intravenously D+3, +4
cyclosporine ADrug
Also called cyclosporine
3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease
| Study group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Chidamide, tablets, 5 mg/tablet, 20 mg orally twice weekly from D-7~+14 Cyclophosphamide: 50 mg/Kg intravenously D+3, +4 Cyclosporine A: intravenously then orally 3 mg/Kg D+5~D+100 Receives: Drug: Chidamide; Drug: Cyclophosphamide; Drug: cyclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
aGVHD
accumulated incidence of aGVHD
Measured: 100 day after infusion of PBSCs
Secondary outcomes (4)
GRFS
GVHD free, relapse free survival
Measured: 3 years after recruitment
DFS
Disease free survival
Measured: 3 years after recruitment
OS
Overall survival
Measured: 3 years after recruitment
cGVHD
accumulated incidence of cGVHD
Measured: 2 yeas after infusion of PBSCs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jan 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
- Investigators
- Ting Liu, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336632
- Sponsor's protocol ID
- HX-GVHD-1
- Status last verified
- Jul 2018
- First submitted
- 6 Nov 2017
- Last updated
- 18 Jul 2018
- 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 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Plus Post-transplantation Cyclophosphamide and Cyclosporine to Prevent Graft-versus-host Disease After Myeloablative Conditioning, Matched Peripheral-blood Stem-cell Transplantation
- ClinicalTrials.gov ID
- NCT03336632
- Acronym / sponsor ID
- HX-GVHD-1
- Conditions
- Leukemia, Acute, MDS
- Keywords
- PBSCT, myeloablative conditioning, HDACi, chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 8 Nov 2017 (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 is to explore the efficacy and safety of introduction of chidamide in PTCy based GVHD prophylaxis in patients undergoing allogeneic PBSCT.
Detailed description
Eligible patients were aged 16 to 65 years, diagnosed with hematologic malignancy, and had a Karnofsky performance score of ≥70% and were candidates for myeloablative HCT. A 8/8 HLA allelic match between the donor and the recipient at HLA-A, HLA-B, HLA-C, and HLA-DRB1 by high-resolution typing was required. The graft source was PBSC.
Patients received a myeloablative conditioning regimen consisting of oral chidamide given twice weekly at a dose of 20 mg from day -7 to 2 weeks post transplantation, intravenous busulfan 3.2 mg/kg from day -6 to -3, intravenous fludarabine 30 mg/m2 and cytarabine 1g/m2 respectively from day -6 to -2. PBSCs were infused on day 0. GVHD prophylaxis was post-transplantation cyclophosphamide (50 mg/kg on day +3, +4) and cyclosporine (started from day +5). In the absence of GVHD, cyclosporine tapering started on day +100 and discontinued on day +180. Minimal residual disease (MRD) was determined by multi-parameter flow cytometry.
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, Drug: Cyclophosphamide, Drug: cyclosporine AChidamide, tablets, 5 mg/tablet, 20 mg orally twice weekly from D-7~+14 Cyclophosphamide: 50 mg/Kg intravenously D+3, +4 Cyclosporine A: intravenously then orally 3 mg/Kg D+5~D+100 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 16 years or older, and ≤ 65 years at time of enrollment
- Signed informed consent
- Hematologic disorder requiring allogeneic hematopoietic cell transplantation
- Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
Key exclusion criteria (7 listed)
- Active infection not controlled with appropriate antimicrobial therapy HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are eligible), or hepatitis C infection
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) ≥4
- Anti-thymocyte globulin (ATG) as part of the conditioning regimen
- Pregnancy
- Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment of cancer within 30 days
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 |
|---|---|---|
| ChidamideAlso: HBI-800020 mg orally, twice weekly from D-7 to D+14 | Drug | Chidamide |
| Cyclophosphamide50 mg/Kg intravenously D+3, +4 | Drug | Chidamide |
| cyclosporine AAlso: cyclosporine3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease | Drug | Chidamide |
Primary outcome
aGVHD
Time frame: 100 day after infusion of PBSCs
accumulated incidence of aGVHD
4 secondary outcomes
GRFS
Time frame: 3 years after recruitment
DFS
Time frame: 3 years after recruitment
OS
Time frame: 3 years after recruitment
cGVHD
Time frame: 2 yeas after infusion of PBSCs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- 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.
Ting Liu, MD study chair
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Cyclophosphamide and cyclosporine A in people with Leukemia, Acute and MDS, run by Sichuan University at 2 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 9 inclusion and 7 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Ji, MD (86-28-85422373, jieji@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aGVHD (time frame: 100 day after infusion of PBSCs). 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 18 Jul 2018.