Graft FailureNCT03717545
Second Transplantation for Graft Failure
A study testing second allogeneic stem cell transplantation in people with Graft Failure and Stem Cell Transplant Complications, run by Peking University People's Hospital at 1 site in China.
Trial summary
Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft Failure, Stem Cell Transplant Complications
- What is being tested?
- second allogeneic stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- graft failure after first allogeneic stem cell transplantation
- no active infection or GVHD or severe organ dysfunction
- sign written informed consent
Who cannot join
- active infection, GVHD, organ failure
- expected life < 28 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
YUQIAN SUN, 861088324577, sunyuqian83@hotmail.com
About this study
Official title: Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation
Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.
- Conditions
- Graft Failure, Stem Cell Transplant Complications
- Being tested
- second allogeneic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second allogeneic stem cell transplantationOther
- Change another donor
- conditioning regimen: FLU/CY/anti-CD25 moAb
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | second allogeneic stem cell transplantation Receives: Other: second allogeneic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
engraftment
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
Measured: 28 days after second transplantation
Secondary outcomes (3)
TRM at 28 day
treatment-related mortality(TRM) was defined as death from any cause other than relapse.
Measured: 28 days after second transplantation
TRM at 100d
treatment-related mortality(TRM) was defined as death from any cause other than relapse.
Measured: day 100 after second transplant
Overall survival at 100d
Overall survival at 100d
Measured: day100 after second transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Graft FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717545
- Sponsor's protocol ID
- 2nd tx for GF
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2018
- Last updated
- 24 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun YQ, Wang Y, Wang FR, Yan CH, Cheng YF, Chen YH, Zhang YY, Han TT, Han W, Suo P, Xu LP, Zhang XH, Liu KY, Huang XJ. Graft Failure in Patients With Hematological Malignancies: A Successful Salvage With a Second Transplantation From a Different Haploidentical Donor. Front Med (Lausanne). 2021 Jun 4;8:604085. doi: 10.3389/fmed.2021.604085. eCollection 2021.
PubMed 34150785
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03717545
- Acronym / sponsor ID
- 2nd tx for GF
- Conditions
- Graft Failure, Stem Cell Transplant Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Oct 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.
Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: second allogeneic stem cell transplantationsecond allogeneic stem cell transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- graft failure after first allogeneic stem cell transplantation
- no active infection or GVHD or severe organ dysfunction
- sign written informed consent
Key exclusion criteria (2 listed)
- active infection, GVHD, organ failure
- expected life < 28 days
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 |
|---|---|---|
| second allogeneic stem cell transplantation1. Change another donor 2. conditioning regimen: FLU/CY/anti-CD25 moAb | Other | intervention arm |
Primary outcome
engraftment
Time frame: 28 days after second transplantation
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
3 secondary outcomes
TRM at 28 day
Time frame: 28 days after second transplantation
TRM at 100d
Time frame: day 100 after second transplant
Overall survival at 100d
Time frame: day100 after second transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Derived from this study: PubMed 34150785Sun YQ, Wang Y, Wang FR, Yan CH, Cheng YF, Chen YH, Zhang YY, Han TT, Han W, Suo P, Xu LP, Zhang XH, Liu KY, Huang XJ. Graft Failure in Patients With Hematological Malignancies: A Successful Salvage With a Second Transplantation From a Different Haploidentical Donor. Front Med (Lausanne). 2021 Jun 4;8:604085. doi: 10.3389/fmed.2021.604085. eCollection 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing second allogeneic stem cell transplantation in people with Graft Failure and Stem Cell Transplant Complications, run by Peking University People's Hospital 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 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 24 Sep 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.
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 YUQIAN SUN (861088324577, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
engraftment (time frame: 28 days after second transplantation). 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 NCT03717545, 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 24 Sep 2020.