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Status unknownNCT03283111Updated Jul 26, 2018

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

An interventional study of autologous stem cell transplantation in Lymphoma, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Peking University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    autologous stem cell transplantation

    Lymphoma patients received autologous stem cell transplantation for the first time

    Biological: autologous stem cell transplantation

Interventions

  • Biologicalautologous stem cell transplantation

    autologous stem cell transplantation

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, 100142, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03283111
Lead sponsor
Peking University
Responsible party
Jun Zhu (Principal Investigator, Clinical Professor, Peking University) — Principal investigator
First posted
Sep 14, 2017
Start date
Jul 2018 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jul 26, 2018

Study contacts

Weiping Liu, MD
Contact
dreaming2217@126.com
8613522796323

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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