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Status unknownNCT03321890Updated Oct 26, 2017

Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

A Phase 2 interventional study of Chidamide and prednisone in Peripheral T-cell Lymphoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.

Read the detailed description

Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.

02

Conditions studied

  • Peripheral T-cell Lymphoma

Keywords

  • relapsed or refractory
  • peripheral T-cell lymphoma
  • Combination therapy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
  2. Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
  3. For various reasons can not be hematopoietic stem cell transplantation in patients;
  4. The age of 18-75 years old, male, female open;
  5. ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
  6. Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L;
  7. The expected survival time ≥ 3 months;
  8. No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment.
  9. Voluntary signature of written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
  2. B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
  3. Patients receiving organ transplants;
  4. Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
  5. Patients with active bleeding;
  6. Liver function abnormalities (total bilirubin> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST> 5 times the upper limit of normal), renal dysfunction Creatinine> 1.5 times the upper limit of normal), electrolyte abnormalities;
  7. Persons with mental disabilities / those who can not obtain informed consent;
  8. Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results;
  9. The investigators determined that they were not fit to participate in the trial.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Combination therapy regimen

    Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate

    Drug: Chidamide · Drug: prednisone · Drug: Cyclophosphamide · Drug: etoposide · Drug: Methotrexate

Interventions

  • DrugChidamide

    Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast

  • Drugprednisone

    oral, 20mg / day,after breakfast

  • DrugCyclophosphamide

    oral, 50mg / day,after lunch

  • Drugetoposide

    oral, 50mg / day,after dinner

  • DrugMethotrexate

    oral, 10mg / times, once a week,after breakfast

05

What researchers measure

Primary outcomes

  1. Objective response rate

    the total proportion of patients with complete response(CR or CRu)and partial response(PR)

    Time frame: every 8 weeks until 2 years after last patient's enrollment

Secondary outcomes

  1. Duration of response

    Duration of complete response(CR or CRu)and partial response(PR)

    Time frame: every 8 weeks until 2 years after last patient's enrollment

  2. Progress Free Survival(PFS)

    Time from treatment until disease progression or death

    Time frame: 2 years

  3. Overall Survival

    Time from treatment until death from any cause

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology,Sun Yat-Sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03321890
Lead sponsor
Sun Yat-sen University
Responsible party
Li Zhiming (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Oct 26, 2017
Start date
Mar 7, 2017
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Oct 26, 2017

Study contacts

Zhiming Li, MD
Contact
lizhm@sysucc.org.cn
86-20-87343765
Yu Wang, MD
Contact
wangyu@sysucc.org.cn
86-20-87343349
Wenqi Jiang, MD
principal investigator · Department of Medical Oncology,Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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