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.

NCT ID: NCT01848652

Last Updated: 2015-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Cerebral Lymphoma B Cell Refractory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MYOCET

Group Type: EXPERIMENTAL

infusion of MYOCET

Intervention Type: DRUG

Interventions

infusion of MYOCET

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian TEMPESCUL, Dr

Role: PRINCIPAL_INVESTIGATOR

University hospital of Brest

Locations

CHRU de Brest

Brest, , France

Hôpital Pitié Salpêtrière

Paris, , France

CHU de Rennes Hôpital Pontchaillou

Rennes, , France

Countries

France

Other Identifiers

RB 12.032 - MYLY

Identifier Type: -

Identifier Source: org_study_id