Myelodysplastic SyndromesPhase 1/2NCT01674985
Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
A Phase 1/2 study testing Microtransplantation in people with Myelodysplastic Syndromes, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Microtransplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2015
- Phase
- Phase 1/2
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
- International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
- bone marrow blasts > 11% or <= 10% and poor cytogenetics;
- lack of an HLA-identical donor;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- adequate cardiac and hepatorenal functions.
Who cannot join
- have an HLA-identical donor
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
About this study
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Microtransplantation
- Keywords
- Decitabine, microtransplantation, myelodysplastic syndromes, chemotherapy
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrotransplantationBiological
Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
| Study group | Role | What they receive |
|---|---|---|
| Decitabine and cytarabine | Experimental | induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days Receives: Biological: Microtransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
Measured: six months
Secondary outcomes (1)
disease-free survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionOct 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Artillery General Hospital
- Responsible party
- Sponsor
- Investigators
- Sheng Hui Ai, M.D, Principal investigator, Affiliated Hospital of Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674985
- Sponsor's protocol ID
- MST/MDS-307PLAH-ASH
- Status last verified
- Jul 2016
- First submitted
- 25 Aug 2012
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.
PubMed 20966170
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01674985
- Acronym / sponsor ID
- MST/MDS-307PLAH-ASH
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Decitabine, microtransplantation, myelodysplastic syndromes, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- The Second Artillery General Hospital
- Study start
- Sep 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2012 (estimated)
- 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 purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine and cytarabine | Experimental | Biological: Microtransplantationinduction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
- International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
- bone marrow blasts > 11% or <= 10% and poor cytogenetics;
- lack of an HLA-identical donor;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
Key exclusion criteria (1 listed)
- have an HLA-identical donor
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 |
|---|---|---|
| MicrotransplantationInfusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) | Biological | Decitabine and cytarabine |
Primary outcome
complete remission
Time frame: six months
1 secondary outcome
disease-free survival
Time frame: three years
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 13 Jul 2016.
- Background: PubMed 20966170Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.
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Myelodysplastic Syndromes
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.
Sheng Hui Ai, M.D principal investigator
Affiliated Hospital of Academy of Military Medical Sciences
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 Microtransplantation in people with Myelodysplastic Syndromes, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 1 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 13 Jul 2016. 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?
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?
complete remission (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674985, which also lists 1 linked publication.
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 13 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.