Graft FailureNCT06512519
Second Haplo-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 fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. Read more about this study
- Who is it for?
- Ages 14 years and older
- 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
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.
Who cannot join
- 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score>2; 5. Expected life time<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yu-qian Sun, M.D., +86-10-88324577, sunyuqian83@hotmail.com
About this study
Official title: A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
- 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 if possible
- Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4)
- GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | second haploidentical 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 of neutrophils
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 (7)
Engraftment of Platelet
Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10^9/L in the absence of platelet transfusion
Measured: 100 days after second transplantation
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 100 day
treatment-related mortality (TRM) was defined as death from any cause other than relapse
Measured: 100 days after second transplantation
GVHD
Both acute and chronic GVHD was diagnosed and graded according to international criteria.
Measured: Participants will be followed for an expected average of 1 year
OS
Overall survival (OS)
Measured: Participants will be followed for an expected average of 1 year
LFS
Leukemia-free survival (LFS) was defined as the survival period with continuous CR.
Measured: Participants will be followed for an expected average of 1 year
CIR
The cumulative incidence of relapse (CIR)
Measured: Participants will be followed for an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, Ruijin Hospital, Zhejiang University, First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Fujian Medical University, Hebei Yanda Ludaopei Hospital, Tongji Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Jiangsu Provincial People's Hospital, Shengjing Hospital, Xinqiao Hospital of Chongqing, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Guangxi Medical University, Anhui Provincial Hospital
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiao-Jun Huang, M.D., Principal investigator, Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512519
- Sponsor's protocol ID
- 2024PHB181-001M
- Status last verified
- Nov 2024
- First submitted
- 16 Jul 2024
- Last updated
- 7 Nov 2024
- Results posted
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
- ClinicalTrials.gov ID
- NCT06512519
- Acronym / sponsor ID
- 2024PHB181-001M
- Conditions
- Graft Failure, Stem Cell Transplant Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, Ruijin Hospital, Zhejiang University, First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Fujian Medical University, Hebei Yanda Ludaopei Hospital, Tongji Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Jiangsu Provincial People's Hospital, Shengjing Hospital, Xinqiao Hospital of Chongqing, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Guangxi Medical University, Anhui Provincial Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jul 2024 (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 fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
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 haploidentical stem cell transplantation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.
Key exclusion criteria (1 listed)
- 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score>2; 5. Expected life time<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
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 if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d) | Other | intervention arm |
Primary outcome
Engraftment of neutrophils
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.
7 secondary outcomes
Engraftment of Platelet
Time frame: 100 days after second transplantation
TRM at 28 day
Time frame: 28 days after second transplantation
TRM at 100 day
Time frame: 100 days after second transplantation
GVHD
Time frame: Participants will be followed for an expected average of 1 year
OS
Time frame: Participants will be followed for an expected average of 1 year
LFS
Time frame: Participants will be followed for an expected average of 1 year
CIR
Time frame: Participants will be followed for an expected average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
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Not yet recruitingPhase 1
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
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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.
Xiao-Jun Huang, M.D. principal investigator
Institute of Hematology, Peking University People's Hospital
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 1 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-qian Sun, M.D. (+86-10-88324577, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment of neutrophils (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?
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 7 Nov 2024.