ChidamidePhase 2NCT03373019
Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study testing Chidamide combined with R-GDP in people with Chidamide and Lymphoma, B-Cell, run by Fudan University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chidamide, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Chidamide combined with R-GDP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesChina
- Study dates
- 21 Dec 2017to 1 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Kai Xue
Shanghai, Shanghai Municipality, 200032
Kai Xue, MD, 13818659448, xuekaishanghai@126.com
- Recruiting
Kai Xue
Shanghai
Kai Xue, MD, 13818659448, xuekaishanghai@126.com
Junning Cao, MD, 13818659448
About this study
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
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.
Read the detailed 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.
- Conditions
- Chidamide, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasm by Histology, Neoplasms, Lymphoproliferative Disorders
- Being tested
- Chidamide combined with R-GDP
- Keywords
- chidamide, R-GDP, diffuse large B-cell lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide combined with R-GDPDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Chidamide combined with R-GDP | Experimental | 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 Receives: Drug: Chidamide combined with R-GDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: 6 weeks
Secondary outcomes (4)
CR
complete response
Measured: 6 weeks
OS
overall survival
Measured: 3 years
3 year PFS
3 year progression free survival
Measured: 3 years
adverse event
adverse event related to treatment
Measured: throughout the treatment period，up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start21 Dec 2017 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChidamideStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Xue, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373019
- Sponsor's protocol ID
- CC-RD1
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03373019
- Acronym / sponsor ID
- CC-RD1
- Conditions
- Chidamide, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasm by Histology, Neoplasms, Lymphoproliferative Disorders
- Keywords
- chidamide, R-GDP, diffuse large B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide combined with R-GDP | Experimental | Drug: Chidamide combined with R-GDPChidamide: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide combined with R-GDPChidamide: 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 | Drug | Chidamide combined with R-GDP |
Primary outcome
ORR
Time frame: 6 weeks
overall response rate
4 secondary outcomes
CR
Time frame: 6 weeks
OS
Time frame: 3 years
3 year PFS
Time frame: 3 years
adverse event
Time frame: throughout the treatment period，up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Chidamide
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Chidamide Combined With Benmelstobart, Nab-paclitaxel, and SBRT as Second-Line Treatment for Advanced BTC
BTC
RecruitingPhase 3
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Lymphoma, T-Cell, Peripheral
RecruitingPhase 2
Chidamide, Lenalidomide, and Rituximab in Newly Diagnosed Elderly/unFit DE-DLBCL
Double Expressor DLBCL, ELDERLY PEOPLE
RecruitingPhase 2
Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
Adult T-cell Leukemia/Lymphoma
RecruitingPhase 2
Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
Neuroblastoma (NB), Neuroblastoma in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide combined with R-GDP in people with Chidamide and Lymphoma, B-Cell, run by Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Xue, MD (13818659448, xuekaishanghai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.