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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03283111
• Other study ID #: CSCO-LWP
• Status: Recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: Peking University
• Contact: Weiping Liu, MD
• Phone: 8613522796323
• Email: dreaming2217[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• autologous stem cell transplantation
autologous stem cell transplantation

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years