Hematologic NeoplasmsNCT03575767
Characteristics and Dynamics of TCR Repertoire in Patients With Hematological Malignancies After Allo-HSCT
An observational study of Hematologic Neoplasms and Hematopoietic Stem Cell Transplantation, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Graft Vs Host Disease
- What is being tested?
- Myeloablative Hematopoietic Stem Cell Transplantation
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2018to 30 Sep 2018
- How long will I take part?
- 1 Year
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
Who may be able to join
- Patients with AML, ALL, MDS, undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
- Patients who have residual peripheral blood mononuclear cell samples freezed up to now which had been disposed at the time of about 1-month, 2-month after allo-HSCT.
- Patients whose residual grafts have been freezed up to now.
Who cannot join
- Patients whose grafts or residual peripheral blood mononuclear cell samples are failed to be thawed.
- Patients whose samples are failed with RNA extraction.
- Patients whose RNA sequencing are failed.
- Patients who died within 2 months after allo-HSCT.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
About this study
Official title: Characteristics and Dynamics of TCR Repertoire in Peripheral Blood of Patients With Hematological Malignancies After Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue for us to look deeply into how these T cells dynamically adjust in the context of the recipient's environment.
The main goal of this research study is to set up a mathematical model based on T cell receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early post-transplantation. This study will deepen the understanding of the molecular mechanisms driving the most deadly post-transplantation complications, and serve as convincing evidence upon which to choose a better donor and a more proper transplantation approach.
This observational trial will perform HTS for TCR β-chain complementarity determining region 3 (CDR3) repertoires of grafts and peripheral blood samples from recipients post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires and clinical outcomes early post-transplantation, especially including GVHD and relapse. The investigators want to know how the antigen environment in recipients drives dynamics of mature T cells from grafts in order to use the new discovered rules to better predict and treat the disease process.
- Conditions
- Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Graft Vs Host Disease, Recurrence
- Being tested
- Myeloablative Hematopoietic Stem Cell Transplantation
- Keywords
- TCR Repertoire, Next Generation Sequencing, ALL, AML, MDS, Myeloablative
- Medical subject headings
- Hematologic Neoplasms, Graft vs Host Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloablative Hematopoietic Stem Cell TransplantationOther
Myeloablative hematopoietic stem cell transplantation from many kinds of donors, including matched related donor, matched unrelated donor, haploidentical related donor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform TCR β-chain CDR3 high-throughput sequencing and TCR repertoire analysis on T cells from the graft and the peripheral blood at the time of 1-month, 2-month after allo-HSCT.
To identify the mechanisms specific for TCR repertoire dynamics and rearrangement characteristics.
Measured: 3 months
Secondary outcomes (2)
Perform longitudinal immune analysis on T cells purified from patients undergoing allogeneic HSCT who develop acute and chronic GVHD, relapse, and virus infectious complications post-transplant.
Characterize the main TCR β-chain CDR3 sequences dynamic change responsible for acute GVHD, chronic GVHD and defects in protective immunity in patients undergoing HSCT.
Measured: 1 year
Perform horizontal comparison analysis on the diversity index of T cells purified from the grafts and the patients undergoing allogeneic HSCT.
Characterize the TCR β-chain CDR3 repertoire dynamic change responsible for acute GVHD, chronic GVHD and defects in protective immunity in patients undergoing HSCT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start8 May 2018
- Primary completion20 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou ImmuQuad Biotechnologies, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575767
- Sponsor's protocol ID
- 307-TCR-NGS-001
- Status last verified
- Oct 2018
- First submitted
- 21 Jun 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Dynamics of TCR Repertoire in Peripheral Blood of Patients With Hematological Malignancies After Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03575767
- Acronym / sponsor ID
- 307-TCR-NGS-001
- Conditions
- Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Graft Vs Host Disease, Recurrence
- Keywords
- TCR Repertoire, Next Generation Sequencing, ALL, AML, MDS, Myeloablative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Hangzhou ImmuQuad Biotechnologies, LLC
- Study start
- 8 May 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 3 Jul 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-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue for us to look deeply into how these T cells dynamically adjust in the context of the recipient's environment.
The main goal of this research study is to set up a mathematical model based on T cell receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early post-transplantation. This study will deepen the understanding of the molecular mechanisms driving the most deadly post-transplantation complications, and serve as convincing evidence upon which to choose a better donor and a more proper transplantation approach.
This observational trial will perform HTS for TCR β-chain complementarity determining region 3 (CDR3) repertoires of grafts and peripheral blood samples from recipients post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires and clinical outcomes early post-transplantation, especially including GVHD and relapse. The investigators want to know how the antigen environment in recipients drives dynamics of mature T cells from grafts in order to use the new discovered rules to better predict and treat the disease process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
Key inclusion criteria (3 listed)
- Patients with AML, ALL, MDS, undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
- Patients who have residual peripheral blood mononuclear cell samples freezed up to now which had been disposed at the time of about 1-month, 2-month after allo-HSCT.
- Patients whose residual grafts have been freezed up to now.
Key exclusion criteria (4 listed)
- Patients whose grafts or residual peripheral blood mononuclear cell samples are failed to be thawed.
- Patients whose samples are failed with RNA extraction.
- Patients whose RNA sequencing are failed.
- Patients who died within 2 months after allo-HSCT.
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 |
|---|---|---|
| Myeloablative Hematopoietic Stem Cell TransplantationMyeloablative hematopoietic stem cell transplantation from many kinds of donors, including matched related donor, matched unrelated donor, haploidentical related donor. | Other | – |
Primary outcome
Perform TCR β-chain CDR3 high-throughput sequencing and TCR repertoire analysis on T cells from the graft and the peripheral blood at the time of 1-month, 2-month after allo-HSCT.
Time frame: 3 months
To identify the mechanisms specific for TCR repertoire dynamics and rearrangement characteristics.
2 secondary outcomes
Perform longitudinal immune analysis on T cells purified from patients undergoing allogeneic HSCT who develop acute and chronic GVHD, relapse, and virus infectious complications post-transplant.
Time frame: 1 year
Perform horizontal comparison analysis on the diversity index of T cells purified from the grafts and the patients undergoing allogeneic HSCT.
Time frame: 1 year
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 4 Oct 2018.
Related trials for Hematologic Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
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 Neoplasms and Hematopoietic Stem Cell Transplantation, run by Affiliated Hospital to Academy of Military Medical Sciences 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 4 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 4 Oct 2018. 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?
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?
Perform TCR β-chain CDR3 high-throughput sequencing and TCR repertoire analysis on T cells from the graft and the peripheral blood at the time of 1-month, 2-month after allo-HSCT. (time frame: 3 months). 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 4 Oct 2018.