Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

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Fudan University

Status and phase

Unknown
Phase 2

Conditions

Double Expressor Lymphoma

Treatments

Drug: Lenalidomide combined with R-CHOP

Study type

Interventional

Funder types

Other

Identifiers

NCT04164368
DE-LYM2019

Details and patient eligibility

About

In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed 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 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 lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Lenalidomide is the second-generation immunomodulatory drug, and its anti-tumor mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this kind of disease.

Enrollment

62 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age range 18-75 years old
  • Eastern Cooperative Oncology Group performance status 0 to 2;
  • Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, and Myc≥40% as well as Bcl-2≥50% through immunohistochemistry;
  • Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥1.0cm in short-diameter by CT or MRI.
  • White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L,platelet ≥ 80×109/L,hemoglobin ≥ 90 g/L. If abnormal factors of peripheral blood caused by bone marrow or spleen involvement of lymphoma, whether to enroll depends on the judgment of researchers
  • 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) ≥ 40 ml/min
  • Ultrasonic cardiogram or nuclide cardiac function showed left ventricle ejection fraction ≥ 50%
  • Women of childbearing potential and men who are sexually active are consent to practicing a highly effective method of birth control. Women of childbearing potential must have a negative serum β-hCG within 2 weeks of enrollment
  • Patients have written informed consent to participate in the study.

Exclusion criteria

  • Prior sever allergy to humanized or mouse derived monoclonal antibody. Unable to receive either lenalidomide or R-CHOP background chemotherapy.
  • History of myocardial diseases, such as unstable angina pectoris, acute myocardial infarction within 6 months of enrollment, congenital heart failure NYHA III/IV
  • Particular kind of DLBCL,such as primary mediastinal/thymic B-cell lymphoma, EBV positive DLBCL, primary cutaneous large B lymphoma, leg type.
  • Presence of CNS involvement
  • Having surgeries ≥ grade 2 within 3 weeks of enrollment.
  • History or now in the treatment process of other malignancies except cured basal cell carcinoma of skin (melanoma not included), and carcinoma in-situ of uterine cervix.
  • More than grade 3 neurotoxicity within 2 two weeks of enrollment
  • Receiving any treatment for lymphoma except short use of corticosteroid (no more than 10 days)
  • History of deep vein thrombosis or pulmonary embolism within 12 months of enrollment
  • Unable or reject to receive antithrombotic treatment
  • Presence of active HBV infection (HBsAg positive and HBV-DNA≥ 104), HCV infection, acquired and congenital immunodeficiency diseases include but not limited to HIV
  • Pregnant or lactating women
  • Previously received organ transplant
  • 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.
  • Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results
  • Patients considered unsuitable to participate in the study by the researchers

Trial design

62 participants in 1 patient group

R2-CHOP
Experimental group
Description:
Lenalidomide combined with rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone
Treatment:
Drug: Lenalidomide combined with R-CHOP

Trial contacts and locations

0

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Central trial contact

Junning Cao

Data sourced from clinicaltrials.gov

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