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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
autologous stem cell transplantation
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous stem cell transplantation

Arm Description

Lymphoma patients received autologous stem cell transplantation for the first time

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2017
Last Updated
July 24, 2018
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03283111
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autologous stem cell transplantation
Arm Type
Experimental
Arm Description
Lymphoma patients received autologous stem cell transplantation for the first time
Intervention Type
Biological
Intervention Name(s)
autologous stem cell transplantation
Intervention Description
autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
2 years
Title
Overall survival
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients should be conformed to all inclusion criteria above. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiping Liu, MD
Phone
8613522796323
Email
dreaming2217@126.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Phone
+86-10-88196596
Email
zj@bjcancer.org
First Name & Middle Initial & Last Name & Degree
Weiping Liu, MD
Phone
+86-10-88196109
Email
dreaming2217@126.com
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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