LymphomaNCT03283111
Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
A study testing autologous stem cell transplantation in people with Lymphoma, run by Peking University at 1 site in China.
Trial summary
This is a retrospective, single-center, non-randomized, non-controlled study. This study aims to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- autologous stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women≥18 years, <65 years;
- Lymphoma patients treated by autologous stem cell transplantation for the first time;
- ECOG ≤ 2;
- Ccr ≥ 50 ml/min;
- ALT, AST and TBIL≤2.5-fold upper normal range;
- Satisfactory heart and lung function;
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- Women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to practice birth control during the study and one year post study;
- Good compliance and sighed informed consent voluntarily.
- Patients should be conformed to all inclusion criteria above.
Who cannot join
- Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;
- Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
- Serious complications;
- LVEF<55%;
- Atopy or allergy to biological product derived from colibacillus;
- Women who are breastfeeding, pregnant or refused to practice contraception;
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- Severe mental or nervous system diseases;
- Severe abnormalities of heart, lung and central nervous system symptoms;
- Patients with sickle cell disease, erythronoclastic anemia or other hematological disease which has an impact on medullary hematopoiesis;
- Enrolled in other study currently or 30 days before screen;
- Patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
- Patients conformed to any of above criteria should be excluded from this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Jun Zhu, MD, +86-10-88196596, zj@bjcancer.org
Weiping Liu, MD, +86-10-88196109, dreaming2217@126.com
About this study
This is a retrospective, single-center, non-randomized, non-controlled study. This study aims to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation.
Read the detailed description
High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is the consolidation treatment for advanced lymphoma patients and approved for treating recurrent and refractory lymphoma by prolonging progression-free survival significantly while also improving quality of life. Evidences to date, have validated that changes of T-lymphocyte subsets after autologous stem cell transplantation associated closely with immunologic reconstitution, and have produced amazing effects in prognosis. Whether T-lymphocyte subsets changes could serve as an effective index for prognosis has been a serious question for lymphoma patients treated by autologous stem cell transplantation. In this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma patients before and after autologous stem cell transplantation, and evaluate the significant effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these patients.
- Conditions
- Lymphoma
- Being tested
- autologous stem cell transplantation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous stem cell transplantationBiological
autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| autologous stem cell transplantation | Experimental | Lymphoma patients received autologous stem cell transplantation for the first time Receives: Biological: autologous stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis. And it would be measured within 2 years.
Measured: 2 years
Overall survival
The investigators would measure the overall survival of participants within 2 years. Overall survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startJul 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283111
- Sponsor's protocol ID
- CSCO-LWP
- Status last verified
- Jul 2018
- First submitted
- 5 Sep 2017
- Last updated
- 26 Jul 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
- ClinicalTrials.gov ID
- NCT03283111
- Acronym / sponsor ID
- CSCO-LWP
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Sep 2017 (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.
This is a retrospective, single-center, non-randomized, non-controlled study. This study aims to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation.
Detailed description
High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is the consolidation treatment for advanced lymphoma patients and approved for treating recurrent and refractory lymphoma by prolonging progression-free survival significantly while also improving quality of life. Evidences to date, have validated that changes of T-lymphocyte subsets after autologous stem cell transplantation associated closely with immunologic reconstitution, and have produced amazing effects in prognosis. Whether T-lymphocyte subsets changes could serve as an effective index for prognosis has been a serious question for lymphoma patients treated by autologous stem cell transplantation. In this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma patients before and after autologous stem cell transplantation, and evaluate the significant effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous stem cell transplantation | Experimental | Biological: autologous stem cell transplantationLymphoma patients received autologous stem cell transplantation for the first time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women≥18 years, <65 years;
- Lymphoma patients treated by autologous stem cell transplantation for the first time;
- ECOG ≤ 2;
- Ccr ≥ 50 ml/min;
- ALT, AST and TBIL≤2.5-fold upper normal range;
Key exclusion criteria (12 listed)
- Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;
- Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
- Serious complications;
- LVEF<55%;
- Atopy or allergy to biological product derived from colibacillus;
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 |
|---|---|---|
| autologous stem cell transplantationautologous stem cell transplantation | Biological | autologous stem cell transplantation |
Primary outcome
Progression-free survival
Time frame: 2 years
Progression-free survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis. And it would be measured within 2 years.
Overall survival
Time frame: 2 years
The investigators would measure the overall survival of participants within 2 years. Overall survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous stem cell transplantation in people with 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 9 inclusion and 12 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 26 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiping Liu, MD (8613522796323, dreaming2217@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). The study lists 2 primary outcomes in all. 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 26 Jul 2018.