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

Peking University

Status: Unknown

Conditions: Lymphoma

Treatments: Biological: autologous stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03283111

CSCO-LWP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Patients should be conformed to all inclusion criteria above.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

autologous stem cell transplantation

Experimental group

Description:

Lymphoma patients received autologous stem cell transplantation for the first time

Treatment:

Biological: autologous stem cell transplantation