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GM-CSF combined IFN-a followed by IL-2 as the immune maintenance therapy for intermediate- and high risk- or elderly acute myeloid leukemia patients unfit for transplantation

GM-CSF combined IFN-a followed by IL-2 as the immune maintenance therapy for intermediate- and high risk- or elderly acute myeloid leukemia patients unfit for transplantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039375
Enrollment
Unknown
Registered
2020-10-25
Start date
2020-10-20
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

Acute myeloid leukemia

Interventions

GIL:GIL regimen

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria (each must meet) 1. Those aged 18 or above, regardless of gender; 2. According to WHO classification in 2016, the patients with AML were definitely diagnosed; 3. According to young adults aged 18-65 years, patients with middle and high risk AML (defined in 2017 ELN guidelines as middle and high risk group or low-risk group with positive minimal residual disease after 4 courses of consolidation chemotherapy) or elderly patients (>= 65 years old) with AML; 4. Adult patients aged 18-65 years old with middle and high risk AML need to complete 4 courses of consolidation therapy, while elderly patients need to complete 2-4 courses of consolidation chemotherapy; 5. Patients who achieved CR after the last consolidation chemotherapy according to the above plan; 6. The object of ECoG 0-2; 7. Subjects with LVEF > 45%; 8. Subjects with normal main organ function: liver function, serum bilirubin <= 2.0 x ULN, serum ALT and AST <= 2.5 x ULN, renal function: Serum Cr <= 2.0 x ULN; 9. Subjects whose life expectancy is more than or equal to 3 months; 10. Subjects with negative pregnancy test; 11. Subjects of informed consent (all studies must sign informed consent form of patients).

Exclusion criteria

Exclusion criteria: Exclusion criteria (one of them is excluded) 1. Patients with a history of autoimmune diseases have symptoms or still need treatment; 2. Patients with renal damage (creatinine > 2 mg / dL or creatinine clearance 115 mmHg), uncontrolled arrhythmia, symptomatic angina pectoris or NYHA III-IV congestive heart failure; patients with myocardial infarction or cerebrovascular events within 6 months; 4. Patients with severe chronic obstructive pulmonary disease complicated with hypoxemia; 5. Patients with inflammatory enteritis, such as Crohn's disease, ulcerative colitis, etc.; 6. Patients with active bacterial, fungal and / or viral infections that cannot be controlled by systemic therapy; 7. Except for patients with skin basal cell carcinoma or cervical carcinoma in situ or early prostate cancer without systemic treatment, or patients with early breast cancer only need surgery. Patients with other malignant tumors in the last 3 years or at the same time; 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
2 years leukemia free survial;

Secondary

MeasureTime frame
MRD negtive rate;2 years overall survial;

Countries

China

Contacts

Public ContactBing Xu

Department of Hematology, The First Affiliated Hospital of Xiamen University

xubingzhangjian@126.com+86 13189096353

Outcome results

None listed

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