Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients

NCT02809573 | Completed Phase 1

• 1 other identifier: CDM103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma.

Conditions

Peripheral T-cell Lymphoma

Keywords

peripheral T-cell lymphoma; PTCL; chidamide; CHOP; phase Ib

Outcome Measures

Primary Outcomes (1)

• dose-limiting toxicity (DLT)

  Day 1 - 21

Secondary Outcomes (9)

• Adverse events

  About 21 weeks

• complete response rate

  About 21 weeks

• Duration of response

  About 21 weeks

• Progression free survival

  About 21 weeks

• Objective response rate

  About 21 weeks

Study Arms (1)

study drugs

EXPERIMENTAL

Lead-in period is 4 days. Patients take a single dose of Chidamide tablet, then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle. Cyclophosphamide, adriacin and vincristine are given in intravenous infusion on Day 1. On Day 1 to 5, prednisone is given orally. Treatment cycles are repeated every 3 weeks .The combination therapy lasts for at most 6 cycles. Patients enter the single agent therapy if attained complete response after 6-cycle combination therapy. In this stage, patients take chidamide orally on Day 1, 4, 8 and 11 of each cycle.

Drug: Chidamide; Drug: cyclophosphamide; Drug: adriacin; Drug: vincristine; Drug: prednisone

Interventions

Chidamide DRUG

In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.

Also known as: CS055

study drugs

cyclophosphamide DRUG

On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m\^2 in 5 minutes after chidamide administration

Also known as: CTX

study drugs

adriacin DRUG

On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m\^2 soon after cyclophosphamide administration.

Also known as: ADR

study drugs

vincristine DRUG

On Day 1, vincristine is given in IV infusion at 1.4 mg/m\^2 after adriacin administration.

Also known as: VCR

study drugs

prednisone DRUG

On Day 1 to 5, prednisone is given orally at 100 mg once a day

Also known as: PED

study drugs

Eligibility Criteria

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

You may qualify if:

• Male and female aged 18-65 years old;
• Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) including:
• PTCL-unspecified;
• Angioimmunoblastic T-cell lymphoma;
• Anaplastic large cell lymphoma, ALK positive or negative;
• Subcutaneous panniculitis T-cell lymphoma;
• Cutaneous / T-cell lymphoma;
• Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
• Patients have not received anti-tumor therapy;
• In any Ann Arbor disease stage;
• ECOG performance status 0-1;
• Patients without bone marrow involvement. The absolute number of neutrophile is no less then 2.0 \* 10\^9/L, platelet no less then 100 \* 10\^9/L. And the concentration of hemoglobin is no less than 110 g/L;
• Life expectancy is no less than 6 months;
• Patients who have signed the Informed Consent Form.

You may not qualify if:

• Patients who have central nervous system or meninges involvements;
• Patients have been treated by radiotherapy, chemotherapy or immunotherapy for PTCL;
• Patients have uncontrollable or significant cardiovascular disease including:
• history of myocardial infarction;
• uncontrollable angina within the 6 months before screening, or taking anti-angina drugs at the time of screening;
• history of congestive heart failure, or the left ventricular ejection fraction (LVEF) is \< 50% at the time of screening;
• clinically significant ventricular arrhythmia such as ventricular tachycardia, ventricular fibrillation or torsades de pointes;
• History of supraventricular arrhythmia or nodal arrhythmia that could not been controlled by drug or need a pacemaker;
• History of cardiomyopathy;
• History of clinically significant QTc interval prolongation, or QTc interval \> 450 ms at screening;
• Coronary disease which is with symptoms and needs drug therapy;
• Patients have undergone organ transplantation;
• Patients with thromboembolic disease, hematencephalon or cerebral infraction within 4 weeks before screening, or patients who are under anticoagulant therapy;
• Patients with clinically significant abnormalities in gastrointestinal tract, such as dysphagia, chronic diarrhea and intestinal obstruction which may affect the uptake,transformation and absorption of the drug;
• Patients with active infections, including active bacterial,viral,fungoid, mycobacterium, parasite infections (but not including hyponychium fungoid infection), or infections which need not be treated by intravenous antibody therapies, or antiviral therapies, or any serious infection need to be treated by hospitalization;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 22, 2016
• Study Start: August 11, 2016
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

CN (1)