Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

NCT04329130 | Unknown Phase 2

• 1 other identifier: B2020-013
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall Response Rate

  4-years

Secondary Outcomes (3)

• PFS

  4-years

• DOR

  4-years

• OS

  4-years

Study Arms (1)

Chidamide combined Lenalidomide

EXPERIMENTAL

Chidamide, 20 mg, twice per week; lenalidomide, 25 mg, d1-21, and rest for 7 days. one treatment cycle per 28 days.For patients with limited lesions and good drug response, local radiotherapy may be assessed by the investigator.

Drug: Chidamide, Lenalidomide

Interventions

Chidamide, Lenalidomide DRUG

All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

Chidamide combined Lenalidomide

Eligibility Criteria

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

You may qualify if:

• peripheral T cell lymphoma (PTCL);
• no remission or relapse after at least one previous systemic treatment；
• at least one assessable lesion；
• years;
• ECOG PS 0-2;
• proper functioning of the major organs;
• expected survival time ≥3 months.

You may not qualify if:

• previous received treatment of HDAC inhibitor or lenalidomide;
• central nervous system (CNS) involvement;
• serious heart problems;
• known allergies to experimental drug ingredients;
• diagnosed with or receiving treatment for a malignancy other than lymphoma;
• uncontrolled active infection, with the exception of tumor-related b-symptom fever;
• unable or unwilling to receive antithrombotic therapy;
• history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Qingqing Cai, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingqing Cai, MD

CONTACT

0086-20-87342823; caiqq@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 physician

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 1, 2020
• Study Start: March 27, 2020
• Primary Completion: March 26, 2022
• Study Completion: March 26, 2025
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CN (1)