Cerebral Lymphoma B Cell Refractory Clinical Trial
— MYLYOfficial title:
Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Brest | Brest | |
| France | Hôpital Pitié Salpêtrière | Paris | |
| France | CHU de Rennes Hôpital Pontchaillou | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest | TEVA |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Answer at treatment | 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 ®). | after 2 cycles of treatment (84 days) | Yes |
| Secondary | Tolerance at treatment | 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. | after each cycle and until the end of follow | Yes |