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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03373019
Other study ID # CC-RD1
Secondary ID
Status Recruiting
Phase Phase 2
First received November 30, 2017
Last updated December 12, 2017
Start date December 21, 2017
Est. completion date March 1, 2021

Study information

Verified date December 2017
Source Fudan University
Contact Kai Xue, MD
Phone 13818659448
Email xuekaishanghai@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is chemotherapy resistance. The investigators conducted this study to evaluate the 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. Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor. It has been approved by China Food and Drug Administration (CFDA) for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population. The investigators' pre-clinical data suggested that this agent might be also efficient in the treatment of relapsed/refractory B cell lymphoma. In this open-label, non-randomized, phase II study, the investigators aimed to observe the efficacy and safety of chidamide combined with R-GDP in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date March 1, 2021
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Chidamide combined with R-GDP
Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off

Locations

Country Name City State
China Kai Xue Shanghai Shanghai
China Kai Xue Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR overall response rate 6 weeks
Secondary CR complete response 6 weeks
Secondary OS overall survival 3 years
Secondary 3 year PFS 3 year progression free survival 3 years
Secondary adverse event adverse event related to treatment throughout the treatment period,up to 6 months
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