Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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ClinicalTrials.gov Identifier: NCT03373019 |
Recruitment Status : Unknown
Verified December 2017 by Kai Xue, MD, Fudan University.
Recruitment status was: Recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Chidamide Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasm by Histology Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Gemcitabine Cisplatin Dexamethasone HDAC Inhibitor | Drug: Chidamide combined with R-GDP | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 63 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation |
Estimated Study Start Date : | December 21, 2017 |
Estimated Primary Completion Date : | June 30, 2019 |
Estimated Study Completion Date : | March 1, 2021 |

Arm | Intervention/treatment |
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Experimental: 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
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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 |
- ORR [ Time Frame: 6 weeks ]overall response rate
- CR [ Time Frame: 6 weeks ]complete response
- OS [ Time Frame: 3 years ]overall survival
- 3 year PFS [ Time Frame: 3 years ]3 year progression free survival
- adverse event [ Time Frame: throughout the treatment period,up to 6 months ]adverse event related to treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages: 18-75 years old
- Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
- Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2
- Informed consent available
- Life expectancy of more than 3 months;
- Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
- Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value)
- Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min
Exclusion Criteria:
- Prior history of treatment of HDAC inhibitor.
- Plan of HSCT in the future
- Significant pericardial effusion showed by chest CT scan
- Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
- Syphilis or human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
- History of organ transplantation
- Serious active infections (including hepatitis)
- Serious neurological or psychiatric history, including dementia or epilepsy.
Termination criteria:
- Withdrew consent
- Researchers think it is necessary to terminate the study;
- Disease progression or death;
- Poor compliance
- Subclinical or clinical cardiac toxicity;
- Unable to continue treatment because of severe toxicity

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373019
Contact: Kai Xue, MD | 13818659448 | xuekaishanghai@126.com |
China, Shanghai | |
Kai Xue | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Kai Xue, MD 13818659448 xuekaishanghai@126.com | |
China | |
Kai Xue | Recruiting |
Shanghai, China | |
Contact: Kai Xue, MD 13818659448 xuekaishanghai@126.com | |
Contact: Junning Cao, MD 13818659448 |
Responsible Party: | Kai Xue, MD, Dr, Fudan University |
ClinicalTrials.gov Identifier: | NCT03373019 |
Other Study ID Numbers: |
CC-RD1 |
First Posted: | December 14, 2017 Key Record Dates |
Last Update Posted: | December 14, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
chidamide R-GDP diffuse large B-cell lymphoma |
Lymphoma Neoplasms Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |
Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Disease Pathologic Processes Neoplasms by Histologic Type |