Thalidomide Combined With R-CHOP in Newly Diagnosed,Untreated Double-expressor Diffuse Large B-Cell Lymphoma Patients

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Fudan University

Status and phase

Unknown
Phase 3

Conditions

Thalidomide

Treatments

Drug: Thalidomide combined with R-CHOP
Drug: R-CHOP

Study type

Interventional

Funder types

Other

Identifiers

NCT03318835
FDSCC LYM2017-01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed,untreated double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)

Full description

Double expressor lymphoma is a subtype of diffuse large B-cell lymphoma defined as having increased expression of MYC and BCL-2 and/or BCL-6 by immunohistochemistry. Patients with double-expressor lymphomas have a poor prognosis when treated with standard chemoimmunotherapy and have increased risk of progression and recurrence. The investigators conducted this study to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed double-expressed, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Thalidomide is a kind of glutamate derivatives, which can inhibit angiogenesis by blocking bFGF and VEGF, and it can also modulate the immune system by co-stimulating T cell proliferation. In addition, thalidomide can also inhibit the IKK activity and block the activation of NF-kB. In this open-label, randomized, phase III study, we are aiming to compare Thalidomide combined with R-CHOP(RT-CHOP) and R-CHOP in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this subtype of lymphoma.

Enrollment

162 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age range ≥18 years old
  • Eastern Cooperative Oncology Group performance status 0 to 2;
  • Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry;
  • Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
  • Patients have written informed consent to participate in the study.
  • Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
  • White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L,platelet ≥ 80×109/L,hemoglobin ≥ 90 g/L
  • total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN
  • serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min

Exclusion criteria

  • Presence of CNS involvement
  • Particular kind of DLBCL,such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.
  • History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.
  • History of severe chronic cutaneous diseases.
  • History of allergic asthma or severe allergic diseases.
  • Uncontrolled hypertension and diabetes.
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • HIV, HCV, or syphilis infection;
  • Presence of active HBV infection(HBV-DNA≥104);
  • Pregnant or lactating women
  • Previously received organ transplant
  • Having usage of Thalidomide;
  • History of deep vein thrombosis
  • Serious uncontrolled infection
  • Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.
  • Severe neurol of mental illness, including dementia and epilepsy.

Trial design

162 participants in 2 patient groups

Thalidomide combined with R-CHOP
Experimental group
Description:
rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21
Treatment:
Drug: Thalidomide combined with R-CHOP
R-CHOP
Active Comparator group
Description:
rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6
Treatment:
Drug: R-CHOP

Trial contacts and locations

0

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Central trial contact

Fang-Fang Lv

Data sourced from clinicaltrials.gov

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