Diffuse large B-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rituximab
Other descriptive name: rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
HUS-The Hospital District of Helsinki and Uusimaa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age ? 18 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe cardiac disease: cardiac function grade 3-4, left ventricular ejection fraction 2.5 x ULN, bilirubin >= 1.5 x ULN, INR > 1.5) • Pregnancy/lactation • Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after completion of treatment • Patients with other severe medical problems, including active infections, cardiac or pulmonary disease, history of PML and with an expected short survival for non-lymphoma reasons • Known HIV positivity • Active or chronic hepatitis B virus (HBV) infection (defined as positive HBsAg serology), or active hepatitis C virus (HCV) infection (defined by antibody serology testing). HBsAg, HBcAb, and HCVAb must be tested during screening. Patients who have protective titers of HBsAb along negative HBsAg after vaccination or prior but cured hepatitis B are eligible. • Vaccination with a live vaccine within one month prior to randomization • Patients with a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for = 5 years prior to enrollment • Earlier treatment containing anthracyclins • Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol • CNS disease as diagnosed by MRI or CSF cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed • Transformed lymphoma • Primary mediastinal B-cell lymphoma • Pleural or peritoneal fluid that cannot be drained safely • Hypersensitity to the active substance or any of the other ingredients • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products • Patients participating in other clinical studies, unless followed for survival • Lower urinary tract constriction, which cannot be treated adequately • Degenerative and toxic encephalopathy • Neuromuscular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Failure free survival rate (FFS) of the patients with biological risk factors compared to similar patients from the historical CRY-04 and CHIC studies, with spesific focus on three years survival.;Secondary Objective: Failure free survival rate (FFS) at 3 years from date of registration of all patients and the patients in the low risk group Toxicy Clinical response rate of all patients and the patients with biological rik factors CNS relapse rate (1,5 year) Progression free survival rate (PFS) at 3 years of all patients and the patients with biological risk factors Overall survival rate (OS) at 3 years of all patients and the patients with biological risk factors Molecular correlates for survival;Primary end point(s): 1.Time to treatment failure ;Timepoint(s) of evaluation of this end point: 1.Time to treatment failure Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression free survival 2. Overall survival (all causes of death) 3. Disease free survival 4. Cause of death;Timepoint(s) of evaluation of this end point: Progression fri overlevelse: Overall overlevelse Disease fri overlevelse Dødsårsag | — |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Public ContactSirpa Leppä
HUH Comprehensive Cancer Centre
Outcome results
None listed