T Cell LymphomaNCT03672084
Allo-HSCT as First-line Consolidation in High-risk PTCL
An observational study of T Cell Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- T Cell Lymphoma
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Dec 2023
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Mature T-cell lymphoma patietnts, stage 2-4, or stage 1 with aa IPI>=0 * age <= 60 years * KPS>=70
Who may be able to join
- Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI>=0
- age <= 60 years
- KPS>=70
Who cannot join
- stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma
- HIV positivity
- major organ dysfunction
- pregnancy
- patient unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
FengRong Wang, 861088326666 ext. 4952
xiaojun huang, M.D.
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation Following Conventional Chemotherapy in High Risk Peripheral T Cell Lymphoma
Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.
Read the detailed description
After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years
- Conditions
- T Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year PFS
progression free survival
Measured: participants will be follow for an expected average of 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2019
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell LymphomaStudies 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
- 50 participants (estimated)
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
- Xiao-Jun Huang, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672084
- Sponsor's protocol ID
- Allo-HSCT for PTCL
- Status last verified
- Jul 2022
- First submitted
- 13 Sep 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation Following Conventional Chemotherapy in High Risk Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03672084
- Acronym / sponsor ID
- Allo-HSCT for PTCL
- Conditions
- T Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Sep 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.
Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.
Detailed description
After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Mature T-cell lymphoma patietnts, stage 2-4, or stage 1 with aa IPI>=0 * age <= 60 years * KPS>=70
Key inclusion criteria (3 listed)
- Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI>=0
- age <= 60 years
- KPS>=70
Key exclusion criteria (5 listed)
- stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma
- HIV positivity
- major organ dysfunction
- pregnancy
- patient unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1 year PFS
Time frame: participants will be follow for an expected average of 365 days
progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
Xiao-Jun Huang, MD principal investigator
Peking University
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 T Cell Lymphoma, 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 5 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 2 Aug 2022. 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 FengRong Wang, MD (8610-88324577, fr.wangt@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year PFS (time frame: participants will be follow for an expected average of 365 days). 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 Aug 2022.