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)
|ClinicalTrials.gov Identifier: NCT01848652|
Recruitment Status : Terminated (The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.)
First Posted : May 7, 2013
Last Update Posted : July 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Lymphoma B Cell Refractory||Drug: infusion of MYOCET||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Drug: infusion of MYOCET
- Answer at treatment [ Time Frame: 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 ®).
- Tolerance at treatment [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848652
|CHRU de Brest|
|Brest, France, 29609|
|Hôpital Pitié Salpêtrière|
|Paris, France, 75651|
|CHU de Rennes Hôpital Pontchaillou|
|Rennes, France, 35033|
|Principal Investigator:||Adrian TEMPESCUL, Dr||University hospital of Brest|