Engraft FailurePhase 3NCT04945096
Outcomes of Patients After Allo-HSCT With Decitabine and NAC
A Phase 3 study testing decitabine, Acetylcysteine and Semustine in people with Engraft Failure and Relapse, run by The First Affiliated Hospital of Soochow University.
Trial summary
The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Engraft Failure, Relapse, GVHD
- What is being tested?
- decitabine, Acetylcysteine and Semustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Dec 2025
- Phase
- Phase 3
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as hematopoietic malignancy;
- Achieved complete remission since the last chemotherapy;
- Age 10-70 years；
- Be willing to receive allo-HSCT, with HLA matched related or HLA matched unrelated, or HLA mismatched related donor.
Who cannot join
- Active infections, severe organ damage (cardiac, renal and/or hepatic dysfunction greater than grade 2 according to the Common Terminology Criteria for Adverse Events V5.0), or any other conditions that make patients ineligible for allo-HSCT;
- Allergic to acetylcysteine or decitabine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Patients After Allogenic Hematopoietic Cell Transplantation With Decitabine-containing Conditioning Regimen and Acetylcysteine Treatment
The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main curative treatment for hematological malignancy. Relapse, graft versus host disease (GVHD) and graft failure are the main causes of treatment failure. Acetylcysteine (NAC) was found to be able to enhance defective HSCs by repairing dysfunctional bone marrow endothelial cells, and overcome the exhaustion of HSCs and enhance the engraftment of HSCs. Decitabine could restore bone marrow microenvironment by repairing endothelial cells and endothelial progenitor cells, as well as cytokines and chemokines which are crucial to HSCs proliferation and differentiation, thereby promote platelet recovery after HSCT. Besides, decitabine therapy was shown to be associated with reduced incidence of GVHD, lower relapse rate, and increased overall survival in several studies. Thereby the investigators will conduct this clinical trial to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients with hematological malignancy after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
- Conditions
- Engraft Failure, Relapse, GVHD
- Being tested
- decitabine, Acetylcysteine, Semustine, Cytarabine, Busulfan
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
Also called 5-aza-2'-deoxycytidine
Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
AcetylcysteineDrug
Also called Acetadote
Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
SemustineDrug
Also called Methyl-CCNU
Semustine: 250 mg/m2/day on day -9.
CytarabineDrug
Also called Cytosine arabinoside
Cytarabine: 2 g/m2 every 12 hours on day -8.
BusulfanDrug
Also called Myleran
Busulfan: 3.2mg/kg/day on day -7 to -5.
CyclophosphamideDrug
Also called Cytoxan
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Cyclosporin ADrug
Also called Cyclosporine
Cyclosporin A: 3mg/kg/d from day -8.
Anti-thymocyte globulinDrug
Also called Thymoglobulin
Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) will be added for transplants with unrelated donor or HLA mismatched donor.
MycophenolateDrug
Also called CellCept
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
| Study group | Role | What they receive |
|---|---|---|
| Acetylcysteine + decitabine | Experimental | Acetylcysteine (1.2g twice a day, oral administration, from day -10 to day 365 after HSCT). Conditional regimen: decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen); semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor. Receives: Drug: decitabine; Drug: Acetylcysteine; Drug: Semustine; Drug: Cytarabine; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Cyclosporin A; Drug: Anti-thymocyte globulin; Drug: Mycophenolate |
| Standard Treatment | Active comparator | Conditional regimen: semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor. Receives: Drug: Semustine; Drug: Cytarabine; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Cyclosporin A; Drug: Anti-thymocyte globulin; Drug: Mycophenolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hematological engraftment rates
The hematological engraftment rates of patients after HSCT.
Measured: 1 year
GVHD rates
The GVHD rates of patients after HSCT.
Measured: 1 year
Relapse rates
The relapse rates of patients after HSCT.
Measured: 1 year
Secondary outcomes (2)
Overall survival
To evaluate the overall survival (days) of patients after HSCT.
Measured: 1 year
Disease free survival
To evaluate the disease free survival (days) of patients after HSCT.
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 posted30 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Engraft FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized after the investigator has verified that all eligibility criteria have been met. Subjects will be randomized in a 1:1 ratio to either Experimental Group (Acetylcysteine + Decitabine) or Active Comparator Group (Standard Treatment).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue Han, Prof., Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945096
- Sponsor's protocol ID
- SOOCHOW-HY-2021-1
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients After Allogenic Hematopoietic Cell Transplantation With Decitabine-containing Conditioning Regimen and Acetylcysteine Treatment
- ClinicalTrials.gov ID
- NCT04945096
- Acronym / sponsor ID
- SOOCHOW-HY-2021-1
- Conditions
- Engraft Failure, Relapse, GVHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Jun 2021 (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 investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main curative treatment for hematological malignancy. Relapse, graft versus host disease (GVHD) and graft failure are the main causes of treatment failure. Acetylcysteine (NAC) was found to be able to enhance defective HSCs by repairing dysfunctional bone marrow endothelial cells, and overcome the exhaustion of HSCs and enhance the engraftment of HSCs. Decitabine could restore bone marrow microenvironment by repairing endothelial cells and endothelial progenitor cells, as well as cytokines and chemokines which are crucial to HSCs proliferation and differentiation, thereby promote platelet recovery after HSCT. Besides, decitabine therapy was shown to be associated with reduced incidence of GVHD, lower relapse rate, and increased overall survival in several studies. Thereby the investigators will conduct this clinical trial to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients with hematological malignancy after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized after the investigator has verified that all eligibility criteria have been met. Subjects will be randomized in a 1:1 ratio to either Experimental Group (Acetylcysteine + Decitabine) or Active Comparator Group (Standard Treatment).
| Arm | Type | Receives |
|---|---|---|
| Acetylcysteine + decitabine | Experimental | Drug: decitabine, Drug: Acetylcysteine, Drug: Semustine, Drug: Cytarabine, Drug: Busulfan, Drug: Cyclophosphamide, Drug: Cyclosporin A, Drug: Anti-thymocyte globulin, Drug: MycophenolateAcetylcysteine (1.2g twice a day, oral administration, from day -10 to day 365 after HSCT). Conditional regimen: decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen); semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor. |
| Standard Treatment | Active comparator | Drug: Semustine, Drug: Cytarabine, Drug: Busulfan, Drug: Cyclophosphamide, Drug: Cyclosporin A, Drug: Anti-thymocyte globulin, Drug: MycophenolateConditional regimen: semustine 250 mg/m2/day on day -9; cytarabine 2 g/m2 every 12 hours on day -8; busulfan 3.2mg/kg/day on day -7 to -5; cyclophosphamide 1.8g/m2/day on day -4 to -3; cyclosporin A: 3mg/kg/d from day -8. Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) and mycophenolate (500mg, oral, twice a day from day -8) were usually added for transplants with unrelated donor or HLA mismatched donor. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as hematopoietic malignancy;
- Achieved complete remission since the last chemotherapy;
- Age 10-70 years；
- Be willing to receive allo-HSCT, with HLA matched related or HLA matched unrelated, or HLA mismatched related donor.
Key exclusion criteria (2 listed)
- Active infections, severe organ damage (cardiac, renal and/or hepatic dysfunction greater than grade 2 according to the Common Terminology Criteria for Adverse Events V5.0), or any other conditions that make patients ineligible for allo-HSCT;
- Allergic to acetylcysteine or decitabine.
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 |
|---|---|---|
| decitabineAlso: 5-aza-2'-deoxycytidineDecitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen) | Drug | Acetylcysteine + decitabine |
| AcetylcysteineAlso: AcetadoteAcetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT. | Drug | Acetylcysteine + decitabine |
| SemustineAlso: Methyl-CCNUSemustine: 250 mg/m2/day on day -9. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| CytarabineAlso: Cytosine arabinosideCytarabine: 2 g/m2 every 12 hours on day -8. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| BusulfanAlso: MyleranBusulfan: 3.2mg/kg/day on day -7 to -5. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| CyclophosphamideAlso: CytoxanCyclophosphamide: 1.8g/m2/day on day -4 to -3. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| Cyclosporin AAlso: CyclosporineCyclosporin A: 3mg/kg/d from day -8. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| Anti-thymocyte globulinAlso: ThymoglobulinAnti-thymocyte globulin (2mg/kg/d on day -5 to day -2) will be added for transplants with unrelated donor or HLA mismatched donor. | Drug | Acetylcysteine + decitabine, Standard Treatment |
| MycophenolateAlso: CellCeptMycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor. | Drug | Acetylcysteine + decitabine, Standard Treatment |
Primary outcome
The hematological engraftment rates
Time frame: 1 year
The hematological engraftment rates of patients after HSCT.
GVHD rates
Time frame: 1 year
The GVHD rates of patients after HSCT.
Relapse rates
Time frame: 1 year
The relapse rates of patients after HSCT.
2 secondary outcomes
Overall survival
Time frame: 1 year
Disease free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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.
Yue Han, Prof. study chair
The First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing decitabine, Acetylcysteine and Semustine in people with Engraft Failure and Relapse, run by The First Affiliated Hospital of Soochow University.
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 4 inclusion and 2 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaqiong Tang, Dr. (18896588075, tangyaqiong@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hematological engraftment rates (time frame: 1 year). The study lists 3 primary outcomes in all. 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 30 Jun 2021.