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A prospective, single-arm evaluating the efficacy and safety of chidamide, CAG and DLI in patients with high risk or relapse hematological malignancies after allogeneic stem cell transplantation

A prospective, single-arm evaluating the efficacy and safety of chidamide, CAG and DLI in patients with high risk or relapse hematological malignancies after allogeneic stem cell transplantation.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017740
Enrollment
Unknown
Registered
2018-08-12
Start date
2018-08-15
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

acute leukemia or myelodysplastic syndrome

Interventions

Case series:chidamide+CAG+DLI

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years male or female; 2. According to the 2008 WHO and 2017 NCCN guidelines, patients were diagnosed as relapse or high risk of acute leukemia or myelodysplastic syndrome after allogeneic stem cell transplantation; 3. ECOG score was 0-3; 4. The expected survival time of patients is more than 4 months. 5. Patients have ability to understand and be willing to sign the informed consent for clinical trial .

Exclusion criteria

Exclusion criteria: 1. Patients who were allergic or have contraindications to the drugs. 2. Patients were at pregnant and lactation period . 3. Patients with active infection. 4. Patients who smoked or indulge in excessive drinking , affected the outcome of the trial. 5. Patients with mental illness or other conditions, can not get informed consent, cooperate with treatment and physical examination. 6. Patients with active bleeding. 7. In the past year, patients have thrombosis, embolism, cerebral hemorrhage etc. 8. Patients were received surgical treatment ,and the operation period was less than 6 weeks. 9. Patients with clinically significant QTC interval prolongation ( time of male is more than 450ms, time of female is more than 470ms), ventricular tachycardia, atrial fibrillation, and above two degree cardiac block. Patients with myocardial infarction within 1 years, congestive heart failure, coronary artery heart with symptom and need to be treated. Patients with heart disease, the ultrasound showed that the area of the pericardial cavity was more than 10mm in the end diastole. 10. Patients with liver dysfunction, total bilirubin > 1.5 times normal upper limit, ALT/AST> 2.5 times normal upper limit. Patients with liver involvement, ALT/AST> 5 times normal upper limit. Patients with renal dysfunction, peripheral blood creatinine > 1.5 times normal upper limit; 11. Patients with II-IV graft-versus-host disease; 12. The researchers decided that participants were not suitable to participate in the clinical experiment .

Design outcomes

Primary

MeasureTime frame
complete remission;partial remission;

Secondary

MeasureTime frame
progression free survival;overall survival;

Countries

China

Contacts

Public ContactChunji Gao

Chinese People's Liberation Army General Hospital

gaochunji301@163.com+86 13911536256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026