A multicenter, single-arm, prospective clinical study of the clinical efficacy and safety treatment of refractory/relapse of acute myeloid leukemia (AML) with CLAAG-M

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16008110

Enrollment

Unknown

Registered

2016-03-16

Start date

2015-03-16

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

Relapse/refractory AML

Interventions

1:Cladirbine 5mg/m2 CIV 2h D1-5

Cytarabine 15mg/m2 d1-10

Retinoid acid (ATRA) 45mg/m2 po D4-6 15mg/m2 po D7-20 G-CSF300ug IH D0- Mitoxntrone 6mg/m2 D1,D3,D5

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria(FAB,testing of immune markers/chromosome/genetic) of AML(except M3),one of the conditions below: (1) patients with high risk and failed in one course of standard induction therapy: Complex Chromosomal(>=3): -5; 5q-; -7; 7q-; 11q23 abnormaled,besides t(9; 22)inv(3)t(3; 3)t(6; 9)t(9; 22)and normal karyotype with separate FLT3-ITD; (2) patients of Secondary AML(including AML with secondary MDS); (3) meet the diagnostic criteria of refractory AML(The guidelines for diagnosis and treatment of acute myeloid leukemia (Relapsed/refractory) in China (2011 edition): failed in the CR after 2 courses of sdandard induction chemotherapy; patients who relapsed after 6 months of the first CR; patients who relapsed after 6 months of the first CR failed again by the original treatment; patients relapsed for twice or more; sustained extramedullary leukemia. (4) Relapsed AML: immature cells in the peripheral blood; bone marrow blasts>5%; extramedullary relapse. 2. ages between 18 and 70; 3. grade 0-3 in ECOG; 4. Expected lifetime>=6weeks; 5. patients who have the ability to understand it are willing to take part in the research and signed in the consent.

Exclusion criteria

Exclusion criteria: 1. acute promyelocytic leukemia(M3); 2. malignant tumour of other progress; 3. patients with severe sepsis or intolerant chemotherapy with orther critical illness; 4. patients of cardiac dysfunction:EF=2mg/dl, AST>2.5 times of ULN, SCr>2.5mg/dl.

Design outcomes

Primary

Measure	Time frame
CR,after 1-2 courses ;	—

Secondary

Measure	Time frame
complet remission rate;early death rate;OS of 2 years;LFS;adverse reaction rate;duration in hospital;Relapse rate;antimicrobial therapy and imported blood products;	—

Countries

China

Contacts

Public ContactLigen, Liu

liuligen@5thhospital.com+86 18918168662

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026