Cerebral Lymphoma B Cell Refractory
Conditions
Keywords
cerebral lymphoma B cell refractory, Myocet, efficacy, safety
Brief summary
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas. This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.
Interventions
DRUGinfusion of MYOCET
Sponsors
Teva Pharmaceuticals USA
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an indication against these treatments. Refractory disease is defined by the absence of objective response to treatment or relapse within 3 months of it. A relapse is defined as disease progression after obtaining a complete or partial response. * Age greater than or equal to 18 years * Performance Index less than 4 * Illness measured by CT or MRI * Hematologic adequate: neutrophils\> 1.5 x 106 / L, platelets\> 100x106 / L * Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the normal laboratory * Adequate renal function: creatinine clearance greater than 60 ml / min * adequate cardiac function measured by ejection fraction of the left ventricle\> 50% by echocardiography * Informed consent signed * Negative pregnancy test for women of childbearing age * Able to understand the arrangements for monitoring the study and to comply * Corticosteroids are only accepted during the first cycle
Exclusion criteria
* Patients with immunosuppression from any cause (HIV, history of transplantation, immunosuppressive treatments ...) * Prior treatment MYOCET ® or other anthracycline * Active infection * Surgery large (more than 3 days hospitalization) within 28 days before enrollment in the study, except for a diagnostic neurosurgical * Hypersensitivity to any component of the treatment * Contraindications to the administration of MYOCET ® and / or dexamethasone Participation in a clinical trial within 4 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Answer at treatment | after 2 cycles of treatment (84 days) | Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance at treatment | after each cycle and until the end of follow | Tolerance, assessed according to the criteria of the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (version 4.03) after administration of each cycle, overall survival, progression-free and disease-free event for complete responses. |
Countries
France
Outcome results
None listed