Chidamide Maintenance After Autologous Hematopoietic Stem Cell Transplantation for Relapsed, Refractory or High-risk Lymphoma

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborators: Hebei Medical University Fourth Hospital; Peking University International Hospital

Criteria

Inclusion Criteria:

1. Patients with B-NHL,NK/T-NHL and HL were confirmed by histopathology examination had received autologous hematopoietic stem cell transplantation (including secondary transplantation). Transplantation interval was 6-8 weeks before in the study. The first diagnostic risk classification or pre-transplant disease status of each type of lymphoma is as follows: 1)B-NHL: patients who are at high risk according to the corresponding international prognostic index in the first diagnosis(IPI>3 /aa IPI >2 /FLIPI>3); Patients must have received at least one first-line induction therapy but did not achieve CR or had relapse after CR; 2)NK/T-NHL: Including all patients, unlimited risk classification and pre-transplant disease status; 3)HL: Patients must have received at least one first-line induction therapy

2. Age 18-70 years, male or female;

3. ECOG performance status 0-1;

4. Organ function should fit the following : Renal function with serum creatinine < 160μmol/L; Liver function with Total bilirubin ≤2 times of normal maximum, ALT and AST≤3 times of normal maximum. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% of expected corrected for hemoglobin. Adequate cardiac function with left ventricular ejection fraction ≥ 50%. No symptomatic cardiac disease;

5. Blood routine test: absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;

6. Life expectancy no less than 3 months;

7. Patients willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Patients relapsed after ASCT

2. Patients with HBsAg positive or HBcAb positive patients also detected HBV-DNA copy number positive;

3. Patients with active HCV infection;

4. Patients with active HIV infection;

5. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and others;

6. Patients with liver cirrhosis or evidence of liver fibrosis;

7. Patients with a QTc longer than 500 ms;

8. Patients with mental disorders or those do not have the ability to consent;

9. Patients with drug abuse, long term alcoholism that may impact the results of the trial;

10. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;

11. Non-appropriate patients for the trial according to the judgment of the investigators;