Early CNS prophylaxis in younger patients with high risk diffuse large B-cell lymphoma.
- Conditions
- Diffuse large B-cell lymphoma (DLBCL)MedDRA version: 14.1Level: PTClassification code 10012825Term: Diffuse large B-cell lymphoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10012824Term: Diffuse large B-cell lymphoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10012826Term: Diffuse large B-cell lymphoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023125-38-SE
- Lead Sponsor
- ordic Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
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
• Patients with at least one of the following criteriae
o More than one extranodal site and elevated LDH
o Testicular lymphoma, stage IIE and higher
o Paranasal sinus and orbital lymphoma
o Large cell infiltration of the bone marrow
o Epidural lymphoma
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 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Conditions that may be compatible with impaired cerebrospinal fluid flow
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method