A single center single arm phase II cinical study of allogeneic CIK cells combined with chemotherapy in de novo AML patients

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16008430

Enrollment

Unknown

Registered

2016-05-07

Start date

2015-06-01

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

AML

Interventions

treatment group:allogeneic CIK cells combined chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) aged >=18 years old; (2) diagnosed as de novo AML(except APL and secondary AML); (3) accept 1-2 cycles of IA or DA chemotherapy and achived CR; (4) ps =3 months; (6) no sever comorbidities as kideny or heart failure; (7) ALT <?5 times of upper limit, bilirubin <?3 times of upper limit,serum creatinie and myocardial enzyme<?2 times of upper limit; (8) HBV-DNA <?10^5; (9) women in manopause should serum ß-HCG (-) and accept contraception till one year after the study; (10) sign the inform consent form.

Exclusion criteria

Exclusion criteria: (1) is receiving another chemotherapy; (2) accepted an operation in the past 4 weeks; (3) is having CNS leukemia; (4) have active hepatitis; (5) have sever comobidities as sever infection,diabities or sever kidney and heart failure; (6) is attending another clinical or in the past 3 montns; (7) breast feeding mother or pregnant women.

Design outcomes

Primary

Measure	Time frame
safety and efficacy;	—

Secondary

Measure	Time frame
OS,RFS;	—

Countries

China

Contacts

Public ContactLu Yue

Sun yat-sen university, cancer center

lvyue@sysucc.org.cn+86 13925084058

Outcome results

None listed

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