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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04164368
Other study ID # DE-LYM2019
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 22, 2019
Est. completion date August 30, 2023

Study information

Verified date May 2024
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date August 30, 2023
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age range 18-75 years old 2. Eastern Cooperative Oncology Group performance status 0 to 2; 3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, and Myc=40% as well as Bcl-2=50% through immunohistochemistry; 4. 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. 5. 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 6. Total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN 7. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) = 40 ml/min 8. Ultrasonic cardiogram or nuclide cardiac function showed left ventricle ejection fraction = 50% 9. 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 ß-hCG within 2 weeks of enrollment 10. Patients have written informed consent to participate in the study. Exclusion Criteria: 1. Prior sever allergy to humanized or mouse derived monoclonal antibody. Unable to receive either lenalidomide or R-CHOP background chemotherapy. 2. History of myocardial diseases, such as unstable angina pectoris, acute myocardial infarction within 6 months of enrollment, congenital heart failure NYHA III/IV 3. Particular kind of DLBCL,such as primary mediastinal/thymic B-cell lymphoma, EBV positive DLBCL, primary cutaneous large B lymphoma, leg type. 4. Presence of CNS involvement 5. Having surgeries = grade 2 within 3 weeks of enrollment. 6. 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. 7. More than grade 3 neurotoxicity within 2 two weeks of enrollment 8. Receiving any treatment for lymphoma except short use of corticosteroid (no more than 10 days) 9. History of deep vein thrombosis or pulmonary embolism within 12 months of enrollment 10. Unable or reject to receive antithrombotic treatment 11. Presence of active HBV infection (HBsAg positive and HBV-DNA= 104), HCV infection, acquired and congenital immunodeficiency diseases include but not limited to HIV 12. Pregnant or lactating women 13. Previously received organ transplant 14. Serious uncontrolled infection 15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder. 16. Severe neurol of mental illness, including dementia and epilepsy. 17. Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results 18. Patients considered unsuitable to participate in the study by the researchers

Study Design


Intervention

Drug:
Lenalidomide combined with R-CHOP
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

Locations

Country Name City State
China 270 Dongan Road, Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other serum cfDNA biomarkers and tissue biomarkers detection of serum and tissue biomarkers in the treatment of double-expressor lymphoma up to 2 years
Primary 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 objective response rate the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment at the end of Cycle 6 (each cycle is 21 days)
Secondary overall survival time between the date of patients sign informed consent and the date of death or the date of last follow-up time 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
Secondary Hematology and non hematology toxicity number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Throughout the treatment period,up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04479267 - Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma Phase 2