A multicenter, randomized, open, prospective study of the clinical efficacy and safety of CLAG regimen in the treatment of relapsed/refractory acute myeloid leukemia (AML)

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040630

Enrollment

Unknown

Registered

2020-12-04

Start date

2019-01-17

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

Relapses of refractory acute myeloid leukemia

Interventions

Different doses groups:Cytarabine at 1g or 2g

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged >=18 years old, male or female; 2) ECOG behavioral status score is 0-3; 3) Expected survival time >=6 weeks; 4) AML(except M3) diagnostic criteria (FAB, immune markers, chromosome and gene detection); 5) No serious heart, lung, liver or kidney diseases. 6) Meet the diagnostic criteria for refractory AML (2018 NCCN criteria): No complete remission was achieved in 2 courses of chemotherapy induced by the standard regimen; Relapse within 12 months after the first complete remission; Those who relapsed 12 months after the first complete remission were reinduced by chemotherapy with the original regimen.2 or more recurrences; Patients with persistent extramedullary leukemia; 7) meet the diagnostic criteria for recurrent AML (2018 NCCN criteria) : after complete remission, leukemia cells or bone marrow primitive cells >5% of the peripheral blood (except for other reasons, such as consolidation chemotherapy, bone marrow reconstruction, etc.) may be re-observed in the patients with extramedullary leukemia cell infiltration; 8) Able to understand and willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with chronic myelogenous leukemia turn white; 2) Acute promyelocytic leukemia (M3 type); 3) Patients with other progressive malignant tumors; 4) Those who have used cladubin treatment regimen before; 5) Patients who cannot control severe infection and patients with severe other basic diseases who cannot tolerate chemotherapy; 6) Patients with cardiac insufficiency: ejection fraction (EF) =2mg/dl, AST > upper limit 2.5 times, serum creatinine (SCr) > 2.5mg /dl; 8) Pregnant and lactating women; 9) HIV-positive, T-SPOT positive, or other TB infected patients; 10) The investigator decides that the participant is not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Grade of prognostic risk in patients with acute myeloid leukemia;Complete response rate;Partial remission rate;Duration of remission;Progression-free survival;Total survival time: 1 year;	—

Countries

China

Contacts

Public ContactAining Sun

The First Affiliated Hospital of Soochow University

sunaining@suda.edu.cn+86 13382101691

Outcome results

None listed

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