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Azacitidine combined with lenalidomide for the prevention of post-transplant leukemia recurrence for patients with refractory/relapse acute myeloid leukemia received allogeneic hematologic stem cell transplantation: single arm clinical trial

Azacitidine combined with lenalidomide prevent relapse of refractory/relapse acute myeloid leukemia after allogeneic hematologic stem cell transplantion: single arm clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061803
Enrollment
Unknown
Registered
2022-07-03
Start date
2020-03-30
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Acute meyloid leukemia

Interventions

Intervention group:Azacitidine 50-75 mg/m2, d1-7
Lenalidomide 5-10 mg/m2, d10-30
6 weeks for one cylce, 8-12 cycles.

Sponsors

The Second Affiliated Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years old, male or female; 2. Diagnosisd with acute myeloid leukemia; 3. No complete remission was achieved after more than 2 courses of initial induction chemotherapy, or disease recurrence occurred in the past; 4. Received allogeneic hematopoietic stem cell transplantation and achieved hematopoietic reconstitution; 5. No history of grade II-IV acute graft-versus-host disease or moderate to severe chronic graft-versus-host disease after transplantation; 6. No active infection requiring intravenous anti infective therapy; 7. No organ dysfunction; 8. Voluntarily participated in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Morphological relapse; 2. Impaired renal or liver function (defined as total bilirubin greater than or equal to 2.5 times the upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase greater than or equal to 3.0 times the ULN, and the estimated glomerular filtration rate less than or equal to 40 ml/min); 3. Received anti-tumor treatment within 28 days before protocol treatment; 4. Allergic to study drug or other contraindications to azacytidine and/or lenalidomide; 5. Poor compliance.

Design outcomes

Primary

MeasureTime frame
2 years disease free survival;

Secondary

MeasureTime frame
2 years overall survival;2 years cumulative recurrence rate;Cumulative incidence rate of acute and chronic graft-versus-host disease;

Countries

China

Contacts

Public ContactKong Peiyan

The Second Affiliated Hospital, Army Medical University

Peiyankong@163.com+86 13228685528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026