A randomised phase II study comparing LEnalidomide plus rituximab, GEmcitabine and methylprednisolone (LR-GEM) to rituximab, gemcitabine, methylprednisolone and cisplatiN (R-GEM-P) in second-line treatment of Diffuse Large B-cell lymphoma (DLBCL) - LEGEND

The Royal Marsden NHS Foundation Trust0 sites92 target enrollmentFebruary 11, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 11, 2013

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Histologically proven CD20\+ Diffuse Large B\-Cell Lymphoma (DLBCL)
•2\.Availability of a tumour block containing adequate histological material for central pathology review and establishment of morphological and ontogenic subtype. Surgically acquired tissue samples are preferred but if core biopsy is the only suitable means by which to acquire a tissue sample then it is suggested than at least 2 cores are taken so that one can be embedded and sent for central review and one retained locally.
•3\.Relapsed after or refractory to one prior line of chemotherapy for DLBCL containing both rituximab and an anthracycline (eg R\-CHOP)
•o‘Relapsed’ is defined as investigator assessed progression after first line treatment
•o‘Refractory’ is defined as patients who progressed during or who did not achieve complete remission with first line treatment (which should include radiotherapy if the patient had localised refractory disease)
•4\.Eligible for combination chemotherapy regimen
•5\.Patient is \=18 years of age on the day of signing informed consent.
•6\.ECOG performance status 0, 1 or 2\.
•7\.Baseline PET/CT scans must demonstrate FDG avid disease compatible with CT defined anatomical tumour sites.
•8\.Adequate bone marrow function: absolute neutrophil count (ANC) \=1\.0x109/l; white blood cell count \= 3x109/l; platelets \= 100x109/l; haemoglobin (Hb) \= 9g/dl (can be post\-transfusion), unless deemed disease related

•1\.Documented or symptomatic central nervous system involvement or leptomeningeal disease.
•2\.Any other clinically significant disease or co\-morbidity which may adversely affect the safe delivery of treatment within this trial, including active or chronic infection, poorly controlled diabetes mellitus, congestive cardiac failure, cardiac arrhythmia, coronary artery disease, cerebrovascular disease, or severe pulmonary disease
•3\.Any other malignancies diagnosed or treated within the last 5 years (other than curatively treated basal cell or squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix or breast).
•4\.Received drug treatment for cancer within 21 days of commencing study treatment.
•5\.Received previous lenalidomide
•6\.Evidence of human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or active hepatitis B infection.
•7\.Patient is pregnant or breastfeeding, or expecting to conceive or father children within one year of finishing study treatment.
•8\.Hypersensitivity or contraindication to any of the study drugs as stated in the SmPCs for each of the study drugs.
•9\.Prior stem cell or solid organ transplant
•10\.Treatment with an investigational product within 30 days prior to enrolment