Dose densified chemoimmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk (aaIPI=2) Diffuse Large B-Cell Lymphoma (NLG-LBC05) - CHIC

• Conditions: Diffuse Large B-Cell Lymphoma (DLBCL); MedDRA version: 12.1Level: LLTClassification code 10012824Term: Diffuse large B-cell lymphoma stage II; MedDRA version: 12.1Level: LLTClassification code 10012825Term: Diffuse large B-cell lymphoma stage III; MedDRA version: 12.1Level: LLTClassification code 10012826Term: Diffuse large B-cell lymphoma stage IV

• Registration Number: EUCTR2010-023125-38-NO
• Lead Sponsor: ordic Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-28
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age =18 < 65 years.
Histologically confirmed CD20+ diffuse large B-cell lymphoma based on WHO 2008 Lymphoma Classification
•Follicular lymphomas grade 3b is allowed
Patients in at least stage II with age adjusted IPI score of 2 or 3:
•Stage III /IV and elevated LDH
•Stage III/IV and WHO performance status 2 - 3
•Stage II and elevated LDH and WHO performance status 2 – 3
And/or patients with
•More than one extranodal site
•Testicular lymphoma, stage IIE and higher
•Paranasal sinus and orbital lymphoma with destruction of bone
•Large cell infiltration of the bone marrow

Previously untreated, except steroids allowed
WHO performance status 0-3
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Severe cardiac disease: cardiac function grade 3-4
Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
Pregnancy/lactation
Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment
Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons
Known HIV positivity
Uncontrolled infectious disease, including meningeal infection
Active cancer except basal cell carcinoma and cervical carcinoma in situ during the last five years
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
Pleural or peritoneal fluid that cannot be drained safely
Hypersensitity to the active substance or any of the other ingredients
Patients participating in other clinical studies, unless followed for survival

Study & Design

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