Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    114
  • sponsor
    Peking University
Updated on 22 January 2021

Summary

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Description

Chidamidea novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

Details
Condition Neoplasms, Experimental
Treatment cyclophosphamide, etoposide, prednisone, vincristine, doxorubicin, Chidamide
Clinical Study IdentifierNCT03617432
SponsorPeking University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Neoplasms, Experimental?
Do you have any of these conditions: Do you have Neoplasms, Experimental??
Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteriaNK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excludedincluding:Peripheral T-cell lymphoma, NOSAngioimmunoblastic T-cell lymphomaAnaplastic large-cell lymphoma, ALK negativeEnteropathy-associated T-cell lymphomaHepatosplenic T-cell lymphomaSubcutaneous panniculitis T-cell lymphomaMycosis fungoidesOther T-cell lymphoma that investigators consider to be appropriate to be enrolled
Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD
Patients should have at least one evaluable foci ( lymph nodes with diameter1.5cm, or evaluable skin foci)
Age 18-70 years, male or female
ECOG performance status 0-2
Absolute neutrophil count 1.5109/L, platelet 75109/L, Hb 90g/L
ALT and serum creatinine <1.5 times of normal maximum
Life expectancy no less than 3 months
Willing to sign the Informed Consent Form

Exclusion Criteria

NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma
Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures
QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment
Patients have undergone organ transplantation
Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment
Patients with active hemorrhage
Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction
Patients with active infection or continuous fever within 14 days prior to enrollment
Had major organ surgery within 6 weeks prior to enrollment
Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum)
Patients with mental disorders or those do not have the ability to consent
Patients with drug abuse, long term alcoholism that may impact the results of the trial
Patients with invasion of central nervous system
Non-appropriate patients for the trial according to the judgment of the investigators
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