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

NCT04164368 | Completed Phase 2

• 1 other identifier: DE-LYM2019
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Double Expressor Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival

  the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason

  From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcomes (3)

• objective response rate

  at the end of Cycle 6 (each cycle is 21 days)

• overall survival

  From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years

• Hematology and non hematology toxicity

  Throughout the treatment period，up to 6 months

Other Outcomes (1)

• serum cfDNA biomarkers and tissue biomarkers

  up to 2 years

Study Arms (1)

R2-CHOP

EXPERIMENTAL

Lenalidomide combined with rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone

Drug: Lenalidomide combined with R-CHOP

Interventions

Lenalidomide combined with R-CHOP DRUG

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 Lenalidomide 25mg PO QD D2-11

Also known as: R2-CHOP

R2-CHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Study Officials

• Junning Cao

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 15, 2019
• Study Start: October 22, 2019
• Primary Completion: August 9, 2021
• Study Completion: August 30, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)