Viewing Study NCT02042690



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Study NCT ID: NCT02042690
Status: COMPLETED
Last Update Posted: 2019-05-29
First Post: 2013-11-29

Brief Title: Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients
Sponsor: Peking University
Organization: Peking University

Study Overview

Official Title: Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia
Status: COMPLETED
Status Verified Date: 2019-05
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 survival of adult patients with standard-risk acute lymphoblastic leukemiaALL need to improve We want to compare the efficacy of haplo-identical hematopoietic stem cell transplantation HSCT with chemotherapy for adultage18-39 years old ALL patients in first phase of complete remission CR1
Detailed Description: Although the high complete remission rate 80-90 can be achieved the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemiaALL is only 25-55 when they receive chemotherapy alone The survival rate can be further improved uo to 50-75 when they receive HLA-matched HSCT However the chance of finding a HLA-matched donor is low especially in China Alternative donor such as halpo-identical related donor might be an choice

Our retrospective analysis showed about 59 overall survival could be achieved when standard-risk adult ALL patients received halpo-identical HSCTTherefore we start this randomization controlled trial to compare the efficacy of haplo-identical HSCT with chemotherapy for adultage18-39 years old ALL patients in CR1

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None