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

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ClinicalTrials.gov Identifier: NCT03283111
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: autologous stem cell transplantation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: autologous stem cell transplantation
Lymphoma patients received autologous stem cell transplantation for the first time
Biological: autologous stem cell transplantation
autologous stem cell transplantation




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    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. Overall survival [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283111


Contacts
Contact: Weiping Liu, MD 8613522796323 dreaming2217@126.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Jun Zhu, MD    +86-10-88196596    zj@bjcancer.org   
Contact: Weiping Liu, MD    +86-10-88196109    dreaming2217@126.com   
Principal Investigator: Jun Zhu, MD         
Sponsors and Collaborators
Peking University

Responsible Party: Jun Zhu, Principal Investigator, Clinical Professor, Peking University
ClinicalTrials.gov Identifier: NCT03283111     History of Changes
Other Study ID Numbers: CSCO-LWP
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases