A randomised study to test the effectiveness of LEnalidomide plus rituximab, GEmcitabine and methylprednisolone (LR-GEM) in comparison to rituximab, gemcitabine, methylprednisolone and cisplatiN (R-GEM-P) in treatment of Diffuse Large B-cell lymphoma (DLBCL) for the second time (when it has relapsed or grown despite the first treatment)

• Conditions: Relapsed or refractory diffuse large B-cell lymphoma.; MedDRA version: 14.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002620-32-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-11
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

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
9.Adequate renal function: calculated creatinine clearance =40ml/minute.
10.Adequate liver function: serum bilirubin =1.5x ULN; ALT/AST =2.5x ULN; ALP =3x ULN (in the absence of liver metastases). If liver metastases are present, ALT, AST or ALP =5x ULN are permitted. Isolated hyperbilirubinaemia due to Gilbert’s disease is acceptable
11.Female patient of childbearing potential (FCBP) must have two negative serum ß-hCG pregnancy tests at baseline.
12.FCBP agreeable to practice sexual abstinence or use two forms of contraception from 28 days prior to the period of study treatment and for 12 months after the last dose of study drugs.
13.Male patients agreeable to practice sexual abstinence use condoms from 28 days prior to the period of study treatment and for 12 months after the last dose of study drugs.
14.Recovery from toxicity from previous anti-cancer treatment to = grade 1

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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
11.Not able to provide fully informed consent because of intellectual impairment or psychiatric disorder
12.Patient unwilling or not able to adhere to the Lenalidomide Pregnancy Prevention Programme (Appendix I)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified