T-cell Lymphoma AdultsNCT06149390
ASCT Versus Chemotherapy as First-Line Consolidation Therapy inT-Cell Lymphoma
An observational study of T-cell Lymphoma Adults, run by Huazhong University of Science and Technology.
Trial summary
To compare the effectiveness of autologous hematopoietic stem cell transplantation and chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic response in T-cell lymphoma through a multicenter retrospective real-world study in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T-cell Lymphoma Adults
- What is being tested?
- consolidation with ASCT
- How many people
- 347 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A preliminary count of approximately 80 patients who received ASCT autologous transplantation and 250 patients who received chemotherapy was conducted as a retrospective cohort study, and all eligible patients were proposed to be included in this study.
Who may be able to join
- Pathological diagnosis of T-cell lymphoma, including, but not limited to, Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL) , ALK-negative anaplastic large cell lymphoma (ALCL, ALK-negative), Enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTCL), and extranodal NK/T-cell lymphoma (ENKTL )
- 18-75 years old;
- Achievement of a complete response (CR) post-chemotherapy;
- Obtaining a complete response (CR) after chemotherapy;-Consistent follow-up visits post-treatment, with comprehensive follow-up data available;
Who cannot join
- Initially diagnosed with ALK-positive Anaplastic Large Cell Lymphoma (ALCL, ALK- - -CR was not achieved after treatment;
- Lack of complete follow-up information or lack of consent for follow-up and data collection
- T-cell lymphoma secondary to other malignancies
About this study
Official title: Observational Clinical Study of Autologous Hematopoietic Stem Cell Transplantation and Chemotherapy as First-Line Consolidation Therapy After Obtaining a Complete Therapeutic Response in T-Cell Lymphoma
To compare the effectiveness of autologous hematopoietic stem cell transplantation and chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic response in T-cell lymphoma through a multicenter retrospective real-world study in China.
Read the detailed description
T-cell lymphoma is characterized by high molecular heterogeneity, high disease aggressiveness, and high chemotherapy resistance rate, and the prognosis is extremely poor. Autologous hematopoietic stem cell transplantation (ASCT) is an important consolidation therapy for patients with T-cell lymphoma who have achieved therapeutic response to chemotherapy, but it is still controversial whether the efficacy of ASCT is significantly better than that of chemotherapy consolidation in patients who have achieved a complete therapeutic response. In this study, the investigators compared the efficacy of ASCT with that of chemotherapy as a first-line consolidation therapy for T-cell lymphoma patients who had achieved a complete therapeutic response in a multicenter real-world study in China. This study included patients with primary T-cell lymphoma diagnosed during 2015-2021 at Shanghai Ruijin Hospital, Peking University People's Hospital, and Wuhan Tongji Hospital, and based on electronic case information, the investigators retrieved the diagnosis, staging, extranodal and bone marrow involvement, and induced and consolidated the efficacy of chemotherapy. The participants were divided into ASCT group and consolidation chemotherapy group according to the consolidation therapy adopted after obtaining complete therapeutic response, and the primary endpoint was adopted as progression-free survival, and the secondary endpoints included overall survival, non-recurrent death, and disease progression/recurrence, so as to explore the efficacy of ASCT and chemotherapy as a first-line consolidation therapy after obtaining a complete therapeutic response in T-cell lymphoma.
- Conditions
- T-cell Lymphoma Adults
- Being tested
- consolidation with ASCT
- Keywords
- NHL, T-cell lymphopma, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consolidation with ASCTDrug
Also called consoliation therapy
high dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion
| Study group | Role | What they receive |
|---|---|---|
| Consoliation with ASCT | consolidation therapy with first-line ASCT in PTCL patients who achieved CR after first-line treatment. Receives: Drug: consolidation with ASCT | |
| non-ASCT | consolidation therapy without first-line ASCT in PTCL patients who achieved CR after first-line treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
death as a result of any cause
Measured: through study completion, an average of 2 year
Secondary outcomes (3)
progression-free survival
disease progression or death as a result of any cause
Measured: through study completion, an average of 2 year
incidence of relapse rate
disease relapse
Measured: through study completion, an average of 2 year
incidence of treatment related mortality rate
death without disease progression or relapse
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jan 2014
- Primary completion1 Jan 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Lymphoma AdultsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Huang, Huazhong University of Science and Technology
- Investigators
- Xiaodong Mo, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149390
- Sponsor's protocol ID
- 2023PHB202-001
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study of Autologous Hematopoietic Stem Cell Transplantation and Chemotherapy as First-Line Consolidation Therapy After Obtaining a Complete Therapeutic Response in T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06149390
- Acronym / sponsor ID
- 2023PHB202-001
- Conditions
- T-cell Lymphoma Adults
- Keywords
- NHL, T-cell lymphopma, adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Ruijin Hospital, West China Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Nov 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.
To compare the effectiveness of autologous hematopoietic stem cell transplantation and chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic response in T-cell lymphoma through a multicenter retrospective real-world study in China.
Detailed description
T-cell lymphoma is characterized by high molecular heterogeneity, high disease aggressiveness, and high chemotherapy resistance rate, and the prognosis is extremely poor. Autologous hematopoietic stem cell transplantation (ASCT) is an important consolidation therapy for patients with T-cell lymphoma who have achieved therapeutic response to chemotherapy, but it is still controversial whether the efficacy of ASCT is significantly better than that of chemotherapy consolidation in patients who have achieved a complete therapeutic response. In this study, the investigators compared the efficacy of ASCT with that of chemotherapy as a first-line consolidation therapy for T-cell lymphoma patients who had achieved a complete therapeutic response in a multicenter real-world study in China. This study included patients with primary T-cell lymphoma diagnosed during 2015-2021 at Shanghai Ruijin Hospital, Peking University People's Hospital, and Wuhan Tongji Hospital, and based on electronic case information, the investigators retrieved the diagnosis, staging, extranodal and bone marrow involvement, and induced and consolidated the efficacy of chemotherapy. The participants were divided into ASCT group and consolidation chemotherapy group according to the consolidation therapy adopted after obtaining complete therapeutic response, and the primary endpoint was adopted as progression-free survival, and the secondary endpoints included overall survival, non-recurrent death, and disease progression/recurrence, so as to explore the efficacy of ASCT and chemotherapy as a first-line consolidation therapy after obtaining a complete therapeutic response in T-cell lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consoliation with ASCT | – | Drug: consolidation with ASCTconsolidation therapy with first-line ASCT in PTCL patients who achieved CR after first-line treatment. |
| non-ASCT | – | –consolidation therapy without first-line ASCT in PTCL patients who achieved CR after first-line treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A preliminary count of approximately 80 patients who received ASCT autologous transplantation and 250 patients who received chemotherapy was conducted as a retrospective cohort study, and all eligible patients were proposed to be included in this study.
Key inclusion criteria (4 listed)
- Pathological diagnosis of T-cell lymphoma, including, but not limited to, Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL) , ALK-negative anaplastic large cell lymphoma (ALCL, ALK-negative), Enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTCL), and extranodal NK/T-cell lymphoma (ENKTL )
- 18-75 years old;
- Achievement of a complete response (CR) post-chemotherapy;
- Obtaining a complete response (CR) after chemotherapy;-Consistent follow-up visits post-treatment, with comprehensive follow-up data available;
Key exclusion criteria (3 listed)
- Initially diagnosed with ALK-positive Anaplastic Large Cell Lymphoma (ALCL, ALK- - -CR was not achieved after treatment;
- Lack of complete follow-up information or lack of consent for follow-up and data collection
- T-cell lymphoma secondary to other malignancies
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 |
|---|---|---|
| consolidation with ASCTAlso: consoliation therapyhigh dose chemotherapy （BCNU, etoposide, cytarabine and melphalan)）and auto stem cells transfusion | Drug | Consoliation with ASCT |
Primary outcome
overall survival
Time frame: through study completion, an average of 2 year
death as a result of any cause
3 secondary outcomes
progression-free survival
Time frame: through study completion, an average of 2 year
incidence of relapse rate
Time frame: through study completion, an average of 2 year
incidence of treatment related mortality rate
Time frame: through study completion, an average of 2 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 29 Nov 2023.
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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.
Xiaodong Mo principal investigator
Peking University
Questions about this trial
What is this clinical trial studying?
An observational study of T-cell Lymphoma Adults, run by Huazhong University of Science and Technology.
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 3 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
overall survival (time frame: through study completion, an average of 2 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 29 Nov 2023.