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Prospective, single arm, multicenter clinical study of veneclax combined with azacitidine sequential unrelated umbilical cord blood micro transplantation in treatment of elderly acute myeloid leukemia

Prospective, single arm, multicenter clinical study of veneclax combined with azacitidine sequential unrelated umbilical cord blood micro transplantation in treatment of elderly acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062462
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Acute myeloid leukemia

Interventions

Experimental group:Veneclax combined with azacitidine sequential unrelated umbilical cord blood micro transplantation

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. AML diagnosed according to WHO diagnostic criteria; 2. AML patients with morphological leukemia-free status (MLFS) level or above after induction therapy with veneclax combined with azacitidine; 3. The subjects are 60 years old (including 60 years old) - 80 years old, regardless of gender or race; 4. Eastern Cooperative Oncology Group (ECOG) physical status <= 2; 5. Healthy liver and kidney function (creatinine<=3*ULN, BUN<=3*ULN, ALT<=3*ULN, AST<=3*ULN, total bilirubin<=3*ULN); 6. Able to comply with the study visit schedule, and understand and comply with all trial protocol requirements; 7. Can take medicine orally. Able and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute promyelocytic leukemia (APL); 2. Patients with relapsed or refractory AML; 3. Receive any trial drug treatment within 28 days before the first day; 4. Any active malignancy, other than focal non-metastatic squamous cell or basal cell skin cancer or carcinoma in situ; patients with a history of malignancy but have been cured (eg, no evidence of malignancy for at least 2 years) can join the group; 5. There are other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 6. There is a serious heart disease, including New York Heart Association (NYHA) class IV congestive heart failure, or any other medical disease that the investigator believes may have an adverse effect on the subjects participating in the study; 7. The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 8. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; 9. Current alcohol and/or drug abuse.

Design outcomes

Primary

MeasureTime frame
Measurable residual disease;

Secondary

MeasureTime frame
Overall survival;Disease free survival;Time to Progress;

Countries

China

Contacts

Public ContactHongyan Tong

The First Affiliated Hospital, College of Medicine, Zhejiang University

hongyantong@aliyun.com+86 13958122357

Outcome results

None listed

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