Clinical trial NCT01848652: 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.
Official 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cerebral Lymphoma B Cell Refractory
Keywords: cerebral lymphoma B cell refractory
Myocet
efficacy
safety
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2013-05-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Answer at treatment
timeFrame: after 2 cycles of treatment (84 days)
Secondary outcomes:
measure: Tolerance at treatment
timeFrame: after each cycle and until the end of follow
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Rennes
country: France
facility: CHU de Rennes Hôpital Pontchaillou
Study officials:
affiliation: University hospital of Brest
name: Adrian TEMPESCUL, Dr
role: PRINCIPAL_INVESTIGATOR
References: