Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL

March 12, 2021 updated by: Huiqiang Huang, Sun Yat-sen University

Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

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).

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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;
  2. Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission;
  3. 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;
  4. At least one measurable lesion with a longest diameter >1.5cm or a short axis >1.0cm;
  5. Age18-75 years;
  6. ECOG performance status 0-2;
  7. Life expectancy no less than 3 months;
  8. 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;
  9. LVEF ≥ 50% by echocardiography;
  10. Contraception during and 4 weeks after the study for patients at child bearing age;
  11. Patients have signed the Informed Consent Form.

Exclusion Criteria:

  1. Patients received Chidamide treatment within 6 months prior to enrollment;
  2. Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma;
  3. Patients with a "currently active" second malignancy;
  4. Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy;
  5. Patients receiving or received corticosteroids within 2 weeks prior to enrollment;
  6. Patients with cumulative life time dose of Doxorubicin > 450mg/m2;
  7. Patients who have been treated with any investigational drug within 4 weeks prior to enrollment;
  8. Women during pregnancy or lactation;
  9. Patients with active infection, medical conditions, or mental disorders;
  10. Patients with active infection of HBV, HCV or HIV;
  11. 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;
  12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
  13. Non-appropriate patients for the trial according to the judgment of the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • epidaza

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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)

Clinical Trials on Chidamide

3
Subscribe