Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04174586|
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues Efficiency||Biological: microtransplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia|
|Actual Study Start Date :||January 22, 2020|
|Estimated Primary Completion Date :||August 31, 2024|
|Estimated Study Completion Date :||August 31, 2024|
Experimental: cord blood group
standard induction and consolidation chemotherapy with cord blood microtransplantation
HLA mismatched donor cord blood infusion
- complete remission rate [ Time Frame: 1 month ]Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.
- time of hematopoietic recovery [ Time Frame: 1 month ]Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
- time to progression [ Time Frame: 2 year ]Measured from complete remission to the relapse
- diease free survival [ Time Frame: 2 year ]Measured from complete remission to the date of death or the date of last follow-up examination.
- overall survival [ Time Frame: 2 year ]Measured from the date of beginning therapy to the date of death or the date of last follow-up examination.
- rate of early mortality [ Time Frame: 1 month ]Death within 4 weeks after initiation of induction therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174586
|Contact: Wen Yao||055162283730 ext firstname.lastname@example.org|
|The First Affiliated Hospital of USTC||Recruiting|
|Hefei, China, 230001|
|Contact: Wen Yao 055162283730 ext 055162283730 email@example.com|
|Study Chair:||Zimin Sun||The First Affiliated Hospital of USTC|