A single-center, single-arm, prospective investigation on the efficacy and safety of the CLAG regimen as salvage therapy for patients with refractory and relapsed acute myeloid leukemia

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-14005741

Enrollment

Unknown

Registered

2014-12-25

Start date

2015-01-12

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

acute myeloid leukemia

Interventions

Case series:CLAG regimen

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The enrolled acute myelogenous leukemia(AML) patients should fulfill all the following requirements: 1. According to WHO diagnosis criteria(FAB, immunizing lablelling, AML should be except for M3; 2. Newly diagnosis AML aged 18 to 60 years; 3. ECOG performance status 3 or below; 4. Primary or secondary AML(containing secondary MDS); 5. The expected survival should be more than 6 weeks; 6. Patients who have not previous allergic reaction to targent medicine in CLAG and FLAG regiments; 7. According to diagnosis criteria of induction therapy failure, refractory and relapsed acute myeloid leukemia (2011 Chinese guidelines for the diagnosis and treatment of relapse and refractory AML): (1) AML patients have induction therapy faillure; (2) AML patients have not achieve complete remission after 2 courses of induction therapy; (3) relapse occured in less than 6 months; (4) replase occured in more than 6 months, failure after secondly induction treatment; (5) recurrence twice or more; and (6) extramedullary leukemia persistence; 8. According to recurrence acute myeloid leukemia diagnosis criteria (2014 NCCN guidelines), achieve complete remission and occuring: (1) blast cells in peripheral blood; (2) blast cells in the bone marrow more than 5%; (3) extramedullary relapse; 9. sign an informed consent before treatment.

Exclusion criteria

Exclusion criteria: 1. chronic myelogenous leukemia or other myeloproliferation disease transformed AML; 2. acute promyelocytic leukemia(M3); 3. with other advanced in malignant tumor; 4. Can't control in patients with severe sepsis and other diseases in patients with severe intolerance to chemotherapy; 5. Patients with cardiac dysfunction: ejection fraction (EF) less than 30%, and New York Heart Association Criteria Grade 2 or above; 6. liver dysfunction and renal dysfunction: serum bilirubin 2mg/dl or above, AST more than 2.5 institutional upper limits of normal, SCr more than 2.5mg/dl; 7. refused to assign informed consent or disapproval of this chinical trial by researchers.

Design outcomes

Primary

Measure	Time frame
ORR;time to CR;	—

Countries

China

Contacts

Public ContactJianda Hu

jdhu@medmail.com.cn+86 13959169016

Outcome results

None listed

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