Hematologic MalignancyNCT05921318
Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
An observational study of Hematologic Malignancy and Stem Cell Transplant Complications, run by Peking University People's Hospital at 1 site in China.
Trial summary
The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Hematologic Malignancy, Stem Cell Transplant Complications
- What is being tested?
- Beijing protocol
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 May 2026
- How long will I take part?
- 3 Years
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor
Who may be able to join
- hematologic malignancy patients
- patients eligible for the transplantation of allogeneic hematopoietic stem cells;
- patients unavailable with HLA matched donor or related haploidentical donor
- voluntary participation in this study and signing the informed consent form.
Who cannot join
- Patients with the severe infections;
- Pregnant or lactating women
- Patients who are not eligible for hematopoietic stem cell transplantation;
- Patients who are enrolled in other clinical trials within 1 month;
- Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
- Patients unable to properly understand or refusing to accept the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaojun Huang, doctor, 8601088326666, xjrm@medmail.com.cn
Xiaojun Huang, Dr.
About this study
Official title: The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
- Being tested
- Beijing protocol
- Keywords
- allogenetic hematopoietic stem cell transplant, HLA locus, Hematologic Malignancy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beijing protocolCombination product
For patients <55 years and HCT-CI≤ 3：Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6 days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days)
For patients ≥ 55 years or HCI-CI>3：Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days).
| Study group | Role | What they receive |
|---|---|---|
| more than 5/10 HLA-mismatched allo-HSCT | more than 5/10 HLA-mismatched allo-HSCT Receives: Combination Product: Beijing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year LFS
defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.
Measured: Participants will be followed for an expected average of 1 years
Secondary outcomes (2)
1-year OS
defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.
Measured: Participants will be followed for an expected average of 1 years
1-year TRM
defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.
Measured: Participants will be followed for an expected average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiaojun Huang, Prof., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921318
- Sponsor's protocol ID
- Highly HLA mismatched HSCT
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
- ClinicalTrials.gov ID
- NCT05921318
- Acronym / sponsor ID
- Highly HLA mismatched HSCT
- Keywords
- allogenetic hematopoietic stem cell transplant, HLA locus, Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Jun 2023 (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 aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| more than 5/10 HLA-mismatched allo-HSCT | – | Combination Product: Beijing protocolmore than 5/10 HLA-mismatched allo-HSCT |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor
Key inclusion criteria (4 listed)
- hematologic malignancy patients
- patients eligible for the transplantation of allogeneic hematopoietic stem cells;
- patients unavailable with HLA matched donor or related haploidentical donor
- voluntary participation in this study and signing the informed consent form.
Key exclusion criteria (6 listed)
- Patients with the severe infections;
- Pregnant or lactating women
- Patients who are not eligible for hematopoietic stem cell transplantation;
- Patients who are enrolled in other clinical trials within 1 month;
- Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
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 |
|---|---|---|
| Beijing protocolFor patients <55 years and HCT-CI≤ 3：Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6 days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days) For patients ≥ 55 years or HCI-CI>3：Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days). | Combination product | more than 5/10 HLA-mismatched allo-HSCT |
Primary outcome
1-year LFS
Time frame: Participants will be followed for an expected average of 1 years
defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.
2 secondary outcomes
1-year OS
Time frame: Participants will be followed for an expected average of 1 years
1-year TRM
Time frame: Participants will be followed for an expected average of 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hematologic Malignancy
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
Bispecific CD19/CD20-Targeted Chimeric Antigen Receptor (CAR) Modified T Cells With 4-1BB and Mutated CD28 Costimulatory Domains in Patients With Relapsed or Refractory CD19+ Hematologic Malignancies
Hematologic Diseases
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Xiaojun Huang, Prof. principal investigator
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?
An observational study of Hematologic Malignancy 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 4 inclusion and 6 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 27 Jun 2023. 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 Yu Wang, Prof. (13552647384, ywyw3172@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year LFS (time frame: Participants will be followed for an expected average of 1 years). 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 27 Jun 2023.