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Clinical study of UCB micro transplantation in the treatment of older patients with acute myeloid leukemia: a multicenter clinical study

Clinical study of UCB micro transplantation in the treatment of older patients with acute myeloid leukemia: a multicenter clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034473
Enrollment
Unknown
Registered
2020-07-06
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Interventions

experimental group:UCB micro transplantation

Sponsors

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Those who meet the following inclusion criteria: (1) Aged 60-80 years, gender and race unlimited; (2) No previous treatment for acute leukemia; (3) Acute myeloid leukemia confirmed by bone marrow morphology, histochemistry and immunotyping (in line with WHO diagnostic criteria); (4) Karnofsky score >= 60%, and the physical state of ECoG <= 2; (5) Cord blood matched at HLA 0-3 / 6 locus and blood group matched; (6) Cord blood with hla-a02 or hla-b27 is preferred.

Exclusion criteria

Exclusion criteria: (1) In the first 4 weeks, the patients had two or more operations; (2) Currently diagnosed as malignant tumor other than AML or under treatment (3) Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated and acute transformation; (4) Stroke or intracranial hemorrhage occurred in the first 6 months; (5) There are clinically significant cardiovascular diseases: Uncontrolled or symptomatic arrhythmias; Congestive heart failure; Myocardial infarction within 6 months before screening; Any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to NYHA). (6) Active human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; RNA PCR positive) or active hepatitis B virus (HBV; DNA PCR positive) infection; (7) Life threatening diseases other than acute myeloid leukemia; (8) Dependence on illegal drugs; (9) Mental disorders or cognitive disorders; (10) Participate in other clinical trials one month before registration; (11) Donor does not meet the requirements: HIV positive, hepatitis B or C or bone marrow disease.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;Myelogram;Hemogram;

Countries

China

Contacts

Public Contactsun zimin

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

zmsun_vip@163.com+86 18963789126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026