Clinical trial NCT03283111: Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
Official title: Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: