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

NCT ID: NCT03373019

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Keywords

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chidamide R-GDP diffuse large B-cell lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Chidamide combined with R-GDP

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kai Xue, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kai Xue

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Kai Xue

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Xue, MD

Role: CONTACT

Phone: 13818659448

Email: [email protected]

Facility Contacts

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Kai Xue, MD

Role: primary

Kai Xue, MD

Role: primary

Junning Cao, MD

Role: backup

Other Identifiers

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CC-RD1

Identifier Type: -

Identifier Source: org_study_id