Back to resultsStudy of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Primary Purpose
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Eligibility Criteria
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.
Sites / Locations
- Department of Medical Oncology, Sun Yat-sen University Cancer Center,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chidamide
Arm Description
Chidamide should be given at a fixed time with fixed dosage
Outcomes
Primary Outcome Measures
objective response rate（ORR）
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.
Secondary Outcome Measures
progression-free survival（PFS）
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
overall survival（OS）
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
Percentage of Participants With Adverse Events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03245905
Brief Title
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
Official Title
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide
Arm Type
Experimental
Arm Description
Chidamide should be given at a fixed time with fixed dosage
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
epidaza
Intervention Description
Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.
Primary Outcome Measure Information:
Title
objective response rate（ORR）
Description
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.
Time Frame
every 6 weeks until 2 years after last patient's enrollment
Secondary Outcome Measure Information:
Title
progression-free survival（PFS）
Description
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Time Frame
every 6 weeks until 2 years after last patient's enrollment
Title
overall survival（OS）
Description
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
Time Frame
every 6 weeks until 2 years after last patient's enrollment
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiqiang Huang, Professor
Phone
+86 020 87343350
Email
huanghq@sysucc.org.cn
Facility Information:
Facility Name
Department of Medical Oncology, Sun Yat-sen University Cancer Center,
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuiQiang Huang
Phone
86-020-87343350
Email
huanghq@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
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