Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous stem cell transplantation

Lymphoma patients received autologous stem cell transplantation for the first time

Group Type EXPERIMENTAL

autologous stem cell transplantation

Intervention Type BIOLOGICAL

autologous stem cell transplantation

Interventions

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autologous stem cell transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Men and women≥18 years, \<65 years;
2. Lymphoma patients treated by autologous stem cell transplantation for the first time;
3. ECOG ≤ 2;
4. Ccr ≥ 50 ml/min;
5. ALT, AST and TBIL≤2.5-fold upper normal range;
6. Satisfactory heart and lung function;
7. 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;
8. Good compliance and sighed informed consent voluntarily.

Exclusion Criteria

1. Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;
2. Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
3. Serious complications;
4. LVEF\<55%;
5. Atopy or allergy to biological product derived from colibacillus;
6. Women who are breastfeeding, pregnant or refused to practice contraception;
7. Severe mental or nervous system diseases;
8. Severe abnormalities of heart, lung and central nervous system symptoms;
9. Patients with sickle cell disease, erythronoclastic anemia or other hematological disease which has an impact on medullary hematopoiesis;
10. Enrolled in other study currently or 30 days before screen;
11. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No