Overview

Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Status:
Unknown status

Trial end date:
2021-03-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fudan University

Criteria

Inclusion Criteria:

1. Ages: 18-75 years old

2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with
standard chemoimmunotherapy

3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)

4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2

5. Informed consent available

6. Life expectancy of more than 3 months;

7. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on
signs of myocardial ischemia, with no previous arrhythmia which need pharmacological
intervention.

8. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;

9. Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of
normal value)

10. Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min

Exclusion Criteria:

1. Prior history of treatment of HDAC inhibitor.

2. Plan of HSCT in the future

3. Significant pericardial effusion showed by chest CT scan

4. Prior history of other cancers except treated cervical or basal cell skin carcinoma,
organ transplantation

5. Syphilis or human immunodeficiency virus (HIV) infection

6. Pregnant or lactating women

7. History of organ transplantation

8. Serious active infections (including hepatitis)

9. Serious neurological or psychiatric history, including dementia or epilepsy.

Termination criteria:

1. Withdrew consent

2. Researchers think it is necessary to terminate the study;

3. Disease progression or death;

4. Poor compliance

5. Subclinical or clinical cardiac toxicity;

6. Unable to continue treatment because of severe toxicity