Peripheral T Cell LymphomaNCT04489264
The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
An observational study of Peripheral T Cell Lymphoma, run by Peking University at 1 site in China.
Trial summary
The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 \& PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Transplant, Autologous
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2020to 30 Nov 2025
- 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 65 years
- All sexes
- Adult, Older adult
Study population: lymphoma patients in several hospitals in China
Who may be able to join
- Patients with confirmed pathological diagnosis of aggressive PTCL
- Age 18-65 years old
- Achieving CR or PR after first-line therapy
Who cannot join
- Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Meng Wu, +861088196109, lxywumeng@foxmail.com
About this study
Official title: A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 \& PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Transplant, Autologous
- Keywords
- Autologous Stem Cell Transplantation
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant, AutologousDrug
high dose chemotherapy followed by autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| ASCT group | patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy Receives: Drug: Transplant, Autologous | |
| Observation group | patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 2-year PFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, Dr., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489264
- Sponsor's protocol ID
- ASCT for PTCL
- Status last verified
- Dec 2020
- First submitted
- 23 Jul 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04489264
- Acronym / sponsor ID
- ASCT for PTCL
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Autologous Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Jul 2020 (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 role of autologous stem cell transplantation (ASCT) in the first remission (CR1 \& PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASCT group | – | Drug: Transplant, Autologouspatients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy |
| Observation group | – | –patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- lymphoma patients in several hospitals in China
Key inclusion criteria (3 listed)
- Patients with confirmed pathological diagnosis of aggressive PTCL
- Age 18-65 years old
- Achieving CR or PR after first-line therapy
Key exclusion criteria (1 listed)
- Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.
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 |
|---|---|---|
| Transplant, Autologoushigh dose chemotherapy followed by autologous stem cell transplantation | Drug | ASCT group |
Primary outcome
PFS
Time frame: 2-year PFS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Peripheral T Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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.
Jun Zhu, Dr. principal investigator
Peking University Cancer Hospital & Institute
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 Peripheral T Cell Lymphoma, run by Peking University 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 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. 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 Jun Zhu, Dr. (+86-13910333346, zhu-jun2017@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2-year PFS). 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 Dec 2020.