MDS-EBPhase 2/3NCT04216355
Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT
A Phase 2/3 study testing Azacitidine and CAG Protocol in people with MDS-EB, run by Fujian Medical University at 1 site in China.
Trial summary
This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) . Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- MDS-EB
- What is being tested?
- Azacitidine and CAG Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2020to Dec 2023
- Phase
- Phase 2/3
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
- Recipient of an allogeneic hematopoietic stem cell transplantation
- Age < 65 years
- ECOG performance status ≤2
- Written informed consent
- No psychological, familial, social, or geographic reason that would compromise clinical follow up
Who cannot join
- Relapsed or refractory advanced MDS
- Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
- Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
- Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Ting Yang, Prof., +86-591-83357896 ext. 8041, yang.hopeting@gmail.com
Jianda Hu, Prof., +86-591-83357896 ext. 8041, jdhu@medmail.com.cn
About this study
Official title: The Feasibility of a Bridging Treatment With Low-dose Azacitidine (AZA) in Combination With Short Term CAG Derived Regimen Prior to Allogeneic Stem Cell Transplantation (Allo-HSCT) in Patients With Advanced Myelodysplastic Syndromes (MDS)
This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .
- Conditions
- MDS-EB
- Being tested
- Azacitidine, CAG Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Low-dose AZA
CAG ProtocolDrug
Short term CAG derived regimen
| Study group | Role | What they receive |
|---|---|---|
| AZA with CAG derived regimen | Experimental | Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC) Receives: Drug: Azacitidine; Drug: CAG Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time to Engraftment
Measured: Baseline to engraftment, assessed minimally 28 days post transplant
Secondary outcomes (3)
Cumulative Incidence of Graft-versus Host Disease
Measured: Up to 2 years
Incidence of systemic infections
Measured: Up to 2 years
Overall survival
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDS-EBStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216355
- Sponsor's protocol ID
- MDS-SCT-01
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Bridging Treatment With Low-dose Azacitidine (AZA) in Combination With Short Term CAG Derived Regimen Prior to Allogeneic Stem Cell Transplantation (Allo-HSCT) in Patients With Advanced Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT04216355
- Acronym / sponsor ID
- MDS-SCT-01
- Conditions
- MDS-EB
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jan 2020 (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 single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZA with CAG derived regimen | Experimental | Drug: Azacitidine, Drug: CAG ProtocolAzacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC) |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
- Recipient of an allogeneic hematopoietic stem cell transplantation
- Age < 65 years
- ECOG performance status ≤2
- Written informed consent
Key exclusion criteria (5 listed)
- Relapsed or refractory advanced MDS
- Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
- Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
- Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
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 |
|---|---|---|
| AzacitidineLow-dose AZA | Drug | AZA with CAG derived regimen |
| CAG ProtocolShort term CAG derived regimen | Drug | AZA with CAG derived regimen |
Primary outcome
Mean Time to Engraftment
Time frame: Baseline to engraftment, assessed minimally 28 days post transplant
3 secondary outcomes
Cumulative Incidence of Graft-versus Host Disease
Time frame: Up to 2 years
Incidence of systemic infections
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azacitidine and CAG Protocol in people with MDS-EB, run by Fujian Medical 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 6 inclusion and 5 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 3 Jan 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ting Yang, Prof.M.D.Ph.D (86-591-86218441, yang.hopeting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Time to Engraftment (time frame: Baseline to engraftment, assessed minimally 28 days post transplant). 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 3 Jan 2020.