Phase II Study Evaluating a Combination of Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy With High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine. (MYLY)

Regional University Hospital Center (CHRU)

Status and phase: Terminated; Phase 2

Conditions: Cerebral Lymphoma B Cell Refractory

Treatments: Drug: infusion of MYOCET

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01848652

RB 12.032 - MYLY

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

MYOCET

Experimental group

Treatment:

Drug: infusion of MYOCET