- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245905
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis. These patients cannot be treated successfully or tolered with the conventional chemotherapy. Epigenetic changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our exploratory research found that Chidamide was effect in some relapsed /refractory B cell lymphoma patients
. Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive relapsed refractory B cell lymphoma failed from second line chemotherapy.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Medical Oncology, Sun Yat-sen University Cancer Center,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), transformed indolent lymphoma (TL), and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission;
- Patients with DLBCL, FL grade3, MALT, LPL and SLL received at least two chemotherapy regimens, and Patients with FL grade1-2 received at least three chemotherapy regimens;
- At least one measurable lesion with a longest diameter >1.5cm or a short axis >1.0cm;
- Age18-75 years;
- ECOG performance status 0-2;
- Life expectancy no less than 3 months;
- Functions within 7 days prior to enrollment: Blood routine test: Hb ≥ 80g/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥60 × 109/L; Total bilirubin ≤ 1.5 times of normal maximum, ALT/AST≤ 2.5 times of normal maximum, for patients with liver metastasis ALT/AST≤ 5 times of normal maximum; serum creatinin≤1.5 times of normal maximum or CCr≥ 60ml/min;
- LVEF ≥ 50% by echocardiography;
- Contraception during and 4 weeks after the study for patients at child bearing age;
- Patients have signed the Informed Consent Form.
Exclusion Criteria:
- Patients received Chidamide treatment within 6 months prior to enrollment;
- Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma;
- Patients with a "currently active" second malignancy;
- Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy;
- Patients receiving or received corticosteroids within 2 weeks prior to enrollment;
- Patients with cumulative life time dose of Doxorubicin > 450mg/m2;
- Patients who have been treated with any investigational drug within 4 weeks prior to enrollment;
- Women during pregnancy or lactation;
- Patients with active infection, medical conditions, or mental disorders;
- Patients with active infection of HBV, HCV or HIV;
- Congestive heart failure (NYHA grade III/IV), myocardial infarction within 6 months, QTc elongation with clinical significance (≥480ms), hypertension BP≥150/100 mmHg and symptomatic coronary heart disease that require treatment;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chidamide
Chidamide should be given at a fixed time with fixed dosage
|
Chidamide 30mg orally BIW.
Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate(ORR)
Time Frame: every 6 weeks until 2 years after last patient's enrollment
|
Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016.
Tumor assessments were performed with CT/MRI with or without PET.
|
every 6 weeks until 2 years after last patient's enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival(PFS)
Time Frame: every 6 weeks until 2 years after last patient's enrollment
|
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
|
every 6 weeks until 2 years after last patient's enrollment
|
overall survival(OS)
Time Frame: every 6 weeks until 2 years after last patient's enrollment
|
Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
|
every 6 weeks until 2 years after last patient's enrollment
|
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to 36 months
|
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
|
Up to 36 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSIIT-B09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
-
Shanghai Miracogen Inc.RecruitingRelapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)China
-
TakedaRecruitingRelapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)United States
-
Regeneron PharmaceuticalsAvailableDiffuse Large B-Cell Lymphoma (DLBCL) | Relapsed or Refractory (R/R) Follicular Lymphoma (FL) | B-Cell Non-Hodgkin Lymphoma (NHL) | High-Grade B-Cell Lymphoma (HGBCL)
-
Miltenyi Biomedicine GmbHActive, not recruitingNon-Hodgkin's Lymphoma | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma | B-cell Lymphoma Refractory | B-cell Lymphoma RecurrentGermany
-
EdiGene (GuangZhou) Inc.The First Affiliated Hospital of Henan University of Science and TechnologyActive, not recruitingRelapsed or Refractory B-cell Malignancy(NHL/ALL)China
-
Eisai Co., Ltd.CompletedRelapsed or Refractory B-cell Non-Hodgkin's LymphomaJapan
-
Eisai Co., Ltd.CompletedRelapsed or Refractory B-cell Non-Hodgkin's LymphomaJapan
-
Zhejiang UniversityYake Biotechnology Ltd.Not yet recruitingRelapsed and/or Refractory Acute Lymphoblastic Leukemia | Relapsed and/or Refractory B-cell Non-Hodgkin's LymphomaChina
-
Cullinan Oncology Inc.RecruitingA Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)NHL | NHL, Relapsed, AdultUnited States
-
PeproMene Bio, Inc.City of Hope Medical CenterRecruitingRelapsed or Refractory B-cell Non-Hodgkin's LymphomaUnited States
Clinical Trials on Chidamide
-
Huiqiang HuangUnknownLymphoma, Extranodal NK-T-Cell | EBV
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Sun Yat-sen UniversityUnknown
-
Sun Yat-sen UniversityRecruitingTriple Negative Breast CancerChina
-
Zhejiang UniversityRecruitingT Lymphoblastic Leukemia/LymphomaChina
-
Sichuan UniversityRecruiting
-
Cancer Institute and Hospital, Chinese Academy...UnknownNatural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeChina
-
Liling ZhangCSPC Ouyi Pharmaceutical Co., Ltd.RecruitingNewly Diagnosed Peripheral T-cell LymphomaChina
-
Peking UniversityPeking University International Hospital; Hebei Medical University Fourth HospitalUnknown
-
Dong meiUnknownAdenocystic CarcinomaChina