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

July 22, 2019 updated by: Chipscreen Biosciences, Ltd.

An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests, etc., of a range of doses of chidamide combined with CHOP in peripheral T-cell lymphoma patients, and to determine the dose limit toxicity and the maximum tolerable dose.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Cancer Hospital, Chinese Academy of Medical Sciences

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female aged 18-65 years old;

  2. 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;
  3. Patients have not received anti-tumor therapy;
  4. In any Ann Arbor disease stage;
  5. ECOG performance status 0-1;
  6. 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;
  7. Life expectancy is no less than 6 months;
  8. Patients who have signed the Informed Consent Form.

Exclusion Criteria:

  1. Patients who have central nervous system or meninges involvements;
  2. Patients have been treated by radiotherapy, chemotherapy or immunotherapy for PTCL;

  3. 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;
  4. Patients have undergone organ transplantation;
  5. Patients with thromboembolic disease, hematencephalon or cerebral infraction within 4 weeks before screening, or patients who are under anticoagulant therapy;
  6. 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;
  7. 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;
  8. Patients who have been conducted the surgery on a major organ in less than 6 weeks;
  9. Hepatic function: Serum total bilirubin > 1.5 fold of normal range; ALT/AST > 2.5 folds of normal range or 5 folds for liver metastasis; Renal function: Serum creatine > 1.5 folds of normal range;
  10. Patients with other malignancies in the past or now (except basal cell carcinoma, squamous-cell carcinoma or carcinoma in situs of cervix that has been adequately treated),unless the malignancy has been radically treated and there has been no evidence of recurrence for 5 years;
  11. Pregnant or lactating women and patients in childbearing age who will not carry out birth control;
  12. Patients with mental disorders, which may affect understanding and execution of informed consent or the compliance of the study;
  13. Drug abuse or long term alcoholism that could affect the evaluation for the study results;
  14. Patients considered by investigators not suitable for the study.

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: study drugs
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
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.
Other Names:
  • CS055
Drug: cyclophosphamide
On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m^2 in 5 minutes after chidamide administration
Other Names:
  • CTX
Drug: adriacin
On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m^2 soon after cyclophosphamide administration.
Other Names:
  • ADR
Drug: vincristine
On Day 1, vincristine is given in IV infusion at 1.4 mg/m^2 after adriacin administration.
Other Names:
  • VCR
Drug: prednisone
On Day 1 to 5, prednisone is given orally at 100 mg once a day
Other Names:
  • PED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dose-limiting toxicity (DLT)
Time Frame: Day 1 - 21
Day 1 - 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: About 21 weeks
About 21 weeks
complete response rate
Time Frame: About 21 weeks
About 21 weeks
Duration of response
Time Frame: About 21 weeks
About 21 weeks
Progression free survival
Time Frame: About 21 weeks
About 21 weeks
Objective response rate
Time Frame: About 21 weeks
About 21 weeks
Overall survival
Time Frame: About 21 weeks
About 21 weeks
Area under the concentration versus time curve (AUC)
Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy
Day 1 of the lead-in period and Day 1 of the combination therapy
Peak plasma concentration (Cmax)
Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy
Day 1 of the lead-in period and Day 1 of the combination therapy
Time of Cmax (Tmax)
Time Frame: Day 1 of the lead-in period and Day 1 of the combination therapy
Day 1 of the lead-in period and Day 1 of the combination therapy

Collaborators and Investigators

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

Sponsor

Chipscreen Biosciences, Ltd.

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 11, 2016

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDM103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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