Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02580071
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2015-10-16
Brief Title:
Chinese Herbal Medicine for Immune Reconstitution Following HSCT in Acute Leukemia Patients
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
An Open Label Non-randomized Clinical Study of Chinese Medicine Sheng-Yu-Tang for Immune Reconstitution Following Peripheral Blood Stem Cell Transplantation in CR1 Complete Remission and Refractory Acute Leukemia Patients
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The treatment options for high-risk acute leukemia patients are limited and these patients are often opt for hematopoietic stem cell transplant HSCT However studies show that prognosis following this last-resort therapy is bleak At times less than 70 of post-HSCT relapsed AML and ALL patients even achieve complete remission median overall survival of these cohorts might not reach one year and 3-year post-HSCT survival rates might be less than 20
The investigators plan to recruit acute leukemia patients from CMUH which are planned to receive HSCT and follow the rate and quality of their immune reconstitution As intervention part of the patients will receive a Chinese medicine herbal formula which they will take for 6 monthsDifferences between the 1-year post-HSCT condition of patients will be examined
The investigators plan to recruit acute leukemia patients from CMUH which are planned to receive HSCT and follow the rate and quality of their immune reconstitution As intervention part of the patients will receive a Chinese medicine herbal formula which they will take for 6 monthsDifferences between the 1-year post-HSCT condition of patients will be examined
Detailed Description:
We hope to enroll 50 high-risk acute leukemia patients after receiving HSCT at China Medical University Hospital Thereupon patients will be consecutively recruited to treatment group 25 patients where they will be prescribed Sheng Yu Tang 聖愈湯 SYT 2 months following HSCT for a period of 6 months in conjunction with the standard-care treatment We predict that not all patients will be interested in taking SYT patients which are not interested in entering treatment group will be offered to join a control group 25 patients which will receive standard-care treatment
Since HSCT patients go through routine blood examinations this study will request to extract a further 20ml of peripheral blood once a month and an additional 20ml of bone marrow at beginning of HSCT and the following routine aspirations est0 3 6 9 12 month Both treatment and control group will be required to contribute peripheral blood and bone marrow sampleBlood samples will be collected until patients reach 1-year post-HSCT and flow cytometry will be used to examine the difference in immune reconstitution rate between the two groups As secondary outcome measurements this study will make use of the minimal residual disease MRD measured frequency of opportunistic infections hospitalizations and results of other routine check-up which recorded in patient history
Since HSCT patients go through routine blood examinations this study will request to extract a further 20ml of peripheral blood once a month and an additional 20ml of bone marrow at beginning of HSCT and the following routine aspirations est0 3 6 9 12 month Both treatment and control group will be required to contribute peripheral blood and bone marrow sampleBlood samples will be collected until patients reach 1-year post-HSCT and flow cytometry will be used to examine the difference in immune reconstitution rate between the two groups As secondary outcome measurements this study will make use of the minimal residual disease MRD measured frequency of opportunistic infections hospitalizations and results of other routine check-up which recorded in patient history
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None