Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    244
  • sponsor
    Peking University
Updated on 23 January 2021
ct scan
cyclophosphamide
vincristine
prednisone
doxorubicin
t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma

Summary

Primary objective of the study is to compare the efficacy and safety of CDOP versus CHOP for newly diagnosed peripheral T-cell lymphoma (PTCL).

Description

This is a open-label, multi-center, randomized, non-inferiority study to compare efficacy and safety of CDOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven newly diagnosed PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 2 cycles, 4cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma
Treatment cyclophosphamide, prednisone, vincristine, doxorubicin, Pegylated Liposomal Doxorubicin
Clinical Study IdentifierNCT03952572
SponsorPeking University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Peripheral T-Cell Lymphoma?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specifiedPTCL-NOS, angioimmunoblastic T cell lymphomaAITL, anaplastic large cell lymphomaALCLand other peripheral T-cell lymphoma(except NK/T cell lymphoma)
Males and females of 18 years of age to 75 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0- 2
At least 1 single size measurable lesions, CT or PET-CT scan shows more than 15mm
Estimated survival time 6 months
Liver function: transaminases3ULNor transaminases3ULN for liver metastasistotal bilirubin 1.5ULNor total bilirubin 2.5ULN for Gilbert's syndrome
Renal function: serum creatinine 1.5ULN or creatinine clearance 60 ml / min ( standard Cockcroft-Gault formula)
peripheral hemogram: WBC3.010^9/L, ANC1.510^9/L, Hb90g/L, PLT7510^12/L
Cardiac ultrasound LVEF55%
New York Heart Association (NYHA) heart function classification is I grade
sign informed consent

Exclusion Criteria

Patients with primary or secondary central nervous system lymphoma
Serious heart disease, including but not limited to
)Significant ventricular arrhythmia or high degree atrioventricular block
(Mobitz II or third degree atrioventricular block); 2) unstable angina; 3)
clinically significant heart valve disease; 4) Electrocardiogram shows
transmural myocardial infarction; 5) Uncontrollable hypertension; 3
interstitial pneumonia, allergic asthma or severe allergic medical history
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), 5.HIV antibody positivity; 6.Acute or chronic active
hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic
active hepatitis C (HCV antibody negatively acceptable; HCV antibody
positivity, HCV RNA negative acceptable) 7.Pregnancy or lactation period
Patients with Organ transplantation 9.Patients with serious uncontroled
acute infection 10.High doses of hormones are contraindicated, such as
uncontrolled hyperglycemia, stomach ulcers or Mental illness, etc
Patients with severe neurological or psychiatric history, including
dementia or epilepsy 12.The researchers considered that patients are not
suitable for the study
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