Higher-risk Myelodysplastic SyndromePhase 4DFMBHSCTNCT01806116
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
A Phase 4 study testing decitabine in people with Higher-risk Myelodysplastic Syndrome and Relapsed /Refractory Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University.
Trial summary
Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients，so that there is the need to… Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Higher-risk Myelodysplastic Syndrome, Relapsed /Refractory Acute Myeloid Leukemia
- What is being tested?
- decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to May 2014
- Phase
- Phase 4
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 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 8- 65 years
- Diseases must be myelodysplastic syndrome and acute myelocytic leukemia
- Must need a bone marrow transplant
- Must have the ability to observe the efficacy and events
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
Who cannot join
- Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
- Must not have a known or suspected hypersensitivity to decitabine
About this study
Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients，so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.
- Being tested
- decitabine
- Keywords
- myelodysplastic syndrome, higher-risk, acute myeloid leukemia, relapsed /refractory, decitabine, hematopoietic cell transplantation, bridge therapy
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| decitabine + transplantation | Experimental | Not described Receives: Drug: decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rates
Measured: three years
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 posted7 Mar 2013 (estimated)
- Study startSep 2009
- Primary completionMar 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Higher-risk Myelodysplastic SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu depei, Phd, Principal investigator, First Affiliated Hospital, Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806116
- Sponsor's protocol ID
- hematology-01
- Acronym
- DFMBHSCT
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 12 Mar 2013
- Results posted
- No