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

NCT03245905 | Unknown Phase 2

• 1 other identifier: CSIIT-B09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Outcome Measures

Primary Outcomes (1)

• 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.

  every 6 weeks until 2 years after last patient's enrollment

Secondary Outcomes (3)

• progression-free survival（PFS）

  every 6 weeks until 2 years after last patient's enrollment

• overall survival（OS）

  every 6 weeks until 2 years after last patient's enrollment

• Percentage of Participants With Adverse Events (AEs)

  Up to 36 months

Study Arms (1)

Chidamide

EXPERIMENTAL

Chidamide should be given at a fixed time with fixed dosage

Drug: Chidamide

Interventions

Chidamide DRUG

Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.

Also known as: epidaza

Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Huiqiang Huang, Professor

CONTACT

+86 020 87343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 10, 2017
• Study Start: August 20, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)