Hematological MalignanciesNCT05103995
Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation
An observational study of Hematological Malignancies and Haploidentical Stem Cell Transplantation, run by First Affiliated Hospital of Zhejiang University at 2 sites in China.
Trial summary
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Hematological Malignancies, Haploidentical Stem Cell Transplantation
- How many people
- 510 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2013to 1 Oct 2021
- Phase
- Observational
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation
Who may be able to join
- 1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.
Who cannot join
- 1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction < 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score > 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Affiliated Jinhua hospital of Zhejiang University
Jinhua, Zhejiang
About this study
Official title: Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
Read the detailed description
The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.
- Being tested
- no intervention
- Keywords
- haploidentical stem cell transplantation, hematological malignancies, ABO incompatibility
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, just observation
| Study group | Role | What they receive |
|---|---|---|
| ABO matched | Donor-recipient ABO matched Receives: Other: no intervention | |
| Minor incompatibility | Donor-recipient minor incompatibility Receives: Other: no intervention | |
| Major incompatibility | Donor-recipient major incompatibility Receives: Other: no intervention | |
| Bidirectional incompatibility | Donor-recipient bidirectional incompatibility Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Overall Survival
5-year Overall Survival
Measured: 5 year
Secondary outcomes (9)
5-year Non-relapse mortality
5-year non-relapse mortality
Measured: 5 year
5-year cumulative incidence of chronic graft versus host disease
5-year cumulative incidence of chronic graft versus host disease
Measured: 5 year
28-day cumulative incidence of neutrophils engraftment
numbers of participants achieved neutrophils engraftment at 28 days post transplantation
Measured: 28 day
28-day cumulative incidence of platelets engraftment
numbers of participants achieved platelets engraftment at 28 days post transplantation
Measured: 28 day
365-day blood transfusion requirements
numbers of blood products transfusion within 365-day after transplantation
Measured: 365 day
cumulative incidence of blood transfusion independence within 60 days after transplantation
numbers of participants achieved blood transfusion independence within 60 days after transplantation
Measured: 60 day
the 5-year cumulative incidence of poor graft function the incidence of poor graft function
numbers of participants occurred poor graft function 5 years post transplantation
Measured: 5 year
the 5-year cumulative incidence of graft failure
numbers of participants occurred graft failure 5 years post transplantation
Measured: 5-year
100-day cumulative incidence of acute graft versus host disease
100-day cumulative incidence of acute graft versus host disease
Measured: 100-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jan 2013
- Primary completion31 Mar 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Jinhua Hospital of Zhejiang University
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103995
- Sponsor's protocol ID
- ZJU-haplo-abo
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05103995
- Acronym / sponsor ID
- ZJU-haplo-abo
- Keywords
- haploidentical stem cell transplantation, hematological malignancies, ABO incompatibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Affiliated Jinhua Hospital of Zhejiang University
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 2 Nov 2021 (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.
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
Detailed description
The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABO matched | – | Other: no interventionDonor-recipient ABO matched |
| Minor incompatibility | – | Other: no interventionDonor-recipient minor incompatibility |
| Major incompatibility | – | Other: no interventionDonor-recipient major incompatibility |
| Bidirectional incompatibility | – | Other: no interventionDonor-recipient bidirectional incompatibility |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation
Key inclusion criteria (1 listed)
- 1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.
Key exclusion criteria (1 listed)
- 1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction < 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score > 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.
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 |
|---|---|---|
| no interventionno intervention, just observation | Other | ABO matched, Bidirectional incompatibility, Major incompatibility, Minor incompatibility |
Primary outcome
5-year Overall Survival
Time frame: 5 year
5-year Overall Survival
9 secondary outcomes
5-year Non-relapse mortality
Time frame: 5 year
5-year cumulative incidence of chronic graft versus host disease
Time frame: 5 year
28-day cumulative incidence of neutrophils engraftment
Time frame: 28 day
28-day cumulative incidence of platelets engraftment
Time frame: 28 day
365-day blood transfusion requirements
Time frame: 365 day
cumulative incidence of blood transfusion independence within 60 days after transplantation
Time frame: 60 day
the 5-year cumulative incidence of poor graft function the incidence of poor graft function
Time frame: 5 year
the 5-year cumulative incidence of graft failure
Time frame: 5-year
100-day cumulative incidence of acute graft versus host disease
Time frame: 100-day
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 2 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Hematological Malignancies
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies and Haploidentical Stem Cell Transplantation, run by First Affiliated Hospital of Zhejiang University at 2 sites 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
5-year Overall Survival (time frame: 5 year). 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 2 Nov 2021.