Response RatePhase 2NCT03663751
Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
A Phase 2 study testing Decitabine in people with Response Rate, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Response Rate
- What is being tested?
- Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all patients after allogeneic stem cell transplantation
- decreasing of donor chimerism to less than 97%
- providing inform consent
Who cannot join
- patients with documented relapse disease
- patients with documented positive MRD+ (>0.1% via flowcytometry or PCR)
- patients with active infection or grade III-IV GVHD
Trial locations and contacts
1 site in 1 country.
China1 site
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.
Read the detailed description
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.
- Conditions
- Response Rate
- Being tested
- Decitabine
- Keywords
- donor chimerism,, decitabine,, allo-HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called LD-DAC
low-dose decitabine: 5mg/m2 daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (>98%). Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Documentation >98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow
Measured: 6 months after initiation of treatment
Secondary outcomes (6)
relapse rate
Documentation of blast in bone marrow >5%
Measured: 12 months after initiation of treatment
engraftment failure
Documentation of pancytopenia with donor chimerism <5%
Measured: 12 months after initiation of treatment
survival rate
event counted as death due to any cause
Measured: 12 months after initiation of treatment
incidence of grade III-IV aGVHD
event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV
Measured: 12 months after initiation of treatment
incidence of moderate to severe chronic GVHD
event counted as documentation of moderate to severe chronic GVHD
Measured: 12 months after initiation of treatment
Overall response
Documentation of complete or partial response
Measured: 6 months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Response RateStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong HU, Principal investigator, Department of Hematology, Rui jin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663751
- Sponsor's protocol ID
- RJ-BMT-2018-1
- Status last verified
- May 2021
- First submitted
- 6 Sep 2018
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03663751
- Acronym / sponsor ID
- RJ-BMT-2018-1
- Conditions
- Response Rate
- Keywords
- donor chimerism,, decitabine,, allo-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Sep 2018 (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.
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.
Detailed description
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: DecitabineThe peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (>98%). |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- all patients after allogeneic stem cell transplantation
- decreasing of donor chimerism to less than 97%
- providing inform consent
Key exclusion criteria (3 listed)
- patients with documented relapse disease
- patients with documented positive MRD+ (>0.1% via flowcytometry or PCR)
- patients with active infection or grade III-IV GVHD
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: LD-DAClow-dose decitabine: 5mg/m2 daily for 5 days | Drug | Treatment |
Primary outcome
Complete response rate
Time frame: 6 months after initiation of treatment
Documentation >98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow
6 secondary outcomes
relapse rate
Time frame: 12 months after initiation of treatment
engraftment failure
Time frame: 12 months after initiation of treatment
survival rate
Time frame: 12 months after initiation of treatment
incidence of grade III-IV aGVHD
Time frame: 12 months after initiation of treatment
incidence of moderate to severe chronic GVHD
Time frame: 12 months after initiation of treatment
Overall response
Time frame: 6 months after initiation of treatment
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 21 May 2021.
- 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.
Jiong HU principal investigator
Department of Hematology, Rui jin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine in people with Response Rate, run by Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 3 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 21 May 2021. 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 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?
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 response rate (time frame: 6 months after initiation of treatment). 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 21 May 2021.