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

NCT03283111 | Unknown

• 1 other identifier: CSCO-LWP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

autologous stem cell transplantation

EXPERIMENTAL

Lymphoma patients received autologous stem cell transplantation for the first time

Biological: autologous stem cell transplantation

Interventions

autologous stem cell transplantation BIOLOGICAL

autologous stem cell transplantation

autologous stem cell transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weiping Liu, MD

CONTACT

8613522796323; dreaming2217@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 14, 2017
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CN (1)