Skip to content

A clinical study of interferon-a-2b in maintenance therapy of low risk acute myeloid leukemia

A clinical study of interferon-a-2b in maintenance therapy of low risk acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035310
Enrollment
Unknown
Registered
2020-08-07
Start date
2020-07-30
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

low risk acute myeloid leukemia

Interventions

IFN-a-2b group:Interferon-a-2b

Sponsors

People's Hospital, Institute of Hematology, Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Low risk AML treated with standard induction chemotherapy; 3. CR1 was achieved and consolidation therapy was completed; 4. 4-6 courses of consolidation therapy was completed, including at least 2 medium dose cytarabine regimen; 5. 6 months after completion of consolidation treatment; 6. CR1 were maintained before receiving the study drug but MRD was positive; 7. The expected survival time is more than 3 months; 8. WHO PS score is 0-1; 9. Patients who are ineligibly for or refuse to accept allogeneic hematopoietic stem cell transplant; 10. Patients voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to drug ingredients, excipients;Allogeneic hematopoietic stem cell transplantation was performed; 2. Patients with acute promyelocytic leukemia;Intermediate- or high-risk AML; 3. Cardiac dysfunction or seriously impaired function of other important organ, serum ALT >= 2.5ULN, serum Cr >= 1.5ULN;Other malignant tumors; 4. Suffering from autoimmune diseases, epilepsy and functional impairment of the central nervous system; 5. Hematopoietic dysfunction; 6. Those who are expected to undergo a bone marrow transplant; 7. Pregnant and lactating women; 8. Having participated in other trials within the last 3 months; 9. Patients the researchers considered inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
MRD negative conversion ratio;

Secondary

MeasureTime frame
OS (3 years);DFS(3 years);relapse rate;

Countries

China

Contacts

Public ContactHao Jiang

Peking University People's Hospital

2516735116@qq.com+86 13601164350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026