Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Safety Issues Clinical Trial

Official title:

Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174586
• Other study ID #: CB-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 22, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2020
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Wen Yao
• Phone: 055162283730
• Email: yaowen0511[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

Description:

The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. de novo acute myeloid leukemia

2. age 60-80

Exclusion Criteria:

1. have no suitable donor or donor refused

2. patient refused to accept donor cells

Related Conditions & MeSH terms

• Efficiency
• Leukemia, Myeloid, Acute
• Safety Issues

Intervention

Biological:
• microtransplantation
HLA mismatched donor cord blood infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital of USTC	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	diease free survival	Measured from complete remission to the date of death or the date of last follow-up examination.	2 year
Other	overall survival	Measured from the date of beginning therapy to the date of death or the date of last follow-up examination.	2 year
Other	rate of early mortality	Death within 4 weeks after initiation of induction therapy	1 month
Primary	complete remission rate	Bone marrow <5% blasts; Absolute neutrophil count >1000/mcL; Platelets =100,000/mcL;No residual evidence of extramedullary disease.	1 month
Primary	time of hematopoietic recovery	Absolute neutrophil count >500/mcL; Platelets =20,000/mcL	1 month
Secondary	time to progression	Measured from complete remission to the relapse	2 year