Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Phase 1

Recruiting

• Conditions: Efficiency; Safety Issues
• Interventions: Biological: microtransplantation

• Registration Number: NCT04174586
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary

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

Detailed 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)

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2020-01-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cord blood group	microtransplantation	standard induction and consolidation chemotherapy with cord blood microtransplantation

Primary Outcome Measures

Name	Time	Method
complete remission rate	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	1 month	Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL

Secondary Outcome Measures

Name	Time	Method
time to progression	2 year	Measured from complete remission to the relapse

Trial Locations

Locations (1)

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, China