Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT02028650
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2014-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
Sponsor:
huishengai
Organization:
Study Overview
Official Title:
HLA-mismatched Peripheral Hematopoietic Stem Cells Infusion in the Treatment of Leukemia Patients Relapse After HLA- Matched Allogeneic Stem Cell Transplantation: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-07
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 relapse leukemia patients after transplantation were divided into two groups randomly. Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without chemotherapy; group D2: patients received second-donor DSI treatment with or without chemotherapy. The second donors were preferably donors who were genetically related and had more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone, cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide, cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.
Detailed Description:
Evaluation indications include bone marrow morphology,hematopoietic recovery (neutrophil and platelet), 100-day transplantation-related mortality (TRM), donor chimerism, acute GVHD, chronic GVHD, disease free survival (DFS), and overall survival (OS). The cut-time of the follow-up was Oct, 2013. DFS was defined as the time between the date of transplantation to the death or relapse. OS was defined as the time from diagnosis to death or to the last date of follow-up until Oct. 2013.
Study Oversight
Has Oversight DMC:
True
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?: