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A multicenter, one-arm, open, prospective study for Decitabine combined with CHAG + cidabenamine in the treatment of relapsed/refractory acute myeloid leukemia (AML)

A multicenter, one-arm, open, prospective study for Decitabine combined with CHAG + cidabenamine in the treatment of relapsed/refractory acute myeloid leukemia (AML)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020372
Enrollment
Unknown
Registered
2018-12-27
Start date
2018-12-27
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Relapsed/refractory acute myeloid leukemia

Interventions

Case series:Decitabine: 15mg/m2 intravenous d2-5 aclaramycin: 20mg/d intravenous administration qod d6, a total of 4-8 doses of harringtonine: 1mg/m2 intravenous administration qd d6-13 Cytarabine: 15

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18-75 years old, male or female; 2) AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease; 3) Patients who have undergone at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) without recurrence or palliative relapse; 4) The ECOG behavior status score is 0-3 points; 5) The expected survival time is = 3 months; 6) Ability to understand and be willing to sign the informed consent form of this trial.

Exclusion criteria

Exclusion criteria: 1) In the past, allergy to the drug contained in the test protocol or to a drug similar to the chemical structure of the test drug; 2) pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures; 3) There are serious active infections; 4) Patients who use drugs and long-term alcoholism to influence the evaluation of test results; 5) Inability to obtain informed consent for mental illness or other conditions cannot be combined with the requirements for completing the trial treatment and inspection procedures; 6) Patients with clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), grade II or higher heart block, myocardial infarction (MI) Patients with coronary heart disease who have congestive heart failure (CHF) within 1 year and who are symptomatic for medical treatment; 7) Heart B-ultrasound shows patients with end-diastolic pericardial cavity dark area width = 10mm; 8) Patients undergoing organ transplantation; 9) Patients with active bleeding; 10) Patients with new diseases such as thrombosis, embolism and cerebral hemorrhage in the past six months; 11) less than 6 weeks after major organ surgery; 12) Abnormal liver function (total bilirubin > 1.5 times the upper limit of normal value, 2.5 times the upper limit of ALT / AST > normal value or 5 times the upper limit of ALT / AST > normal value in patients with liver invasion), abnormal renal function (serum Creatinine > 1.5 times the upper limit of normal); 13) The investigator determined that it was not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactWei Xudong

He'nan Cancer Hospital

weixudong63@126.com+86 13837169301

Outcome results

None listed

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