Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2023
CompletedFirst Submitted
Initial submission to the registry
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2025
CompletedSeptember 18, 2023
September 1, 2023
1 year
September 11, 2023
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
gut microbiota
diversity and composition of the gut microbiota
From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
efficacy of CAR-T therapy
CR，PR and NR
six months
toxicity of CAR-T therapy
Adverse events are evaluated with CTCAE V5.0
six months
Eligibility Criteria
Patients with hematological malignancies who were proposed for CAR-T treatment at the First Affiliated Hospital of Soochow University were enrolled in our study.
You may qualify if:
- Age 16-65 years.
- Hematologic malignancies intended for CAR-T therapy.
- Expected survival time ≥ 3 months (according to investigator's judgement).
- Left ventricular ejection fractions ≥ 55% by echocardiography.
- ALT / AST \<3 times of normal amounts.
- Creatinine\<2.0mg/dl.
- PT and APPT \<2 times of normal amounts.
- Karnofsky performance status ≥ 60.
- The ECOG score ≤2 points.
You may not qualify if:
- Pregnant (or lactating) women;
- Uncontrolled active infection；
- Active infection of hepatitis B virus or hepatitis C virus；
- Human immunodeficiency virus (HIV) positive；
- Patients with a history of myocardial infarction or severe arrhythmia within six months or those with class III or IV cardiac function according to the New York classification；
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Biospecimen
feces
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaowen Tang, PhD
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2023
First Posted
September 18, 2023
Study Start
September 3, 2023
Primary Completion
September 2, 2024
Study Completion
March 2, 2025
Last Updated
September 18, 2023
Record last verified: 2023-09