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)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|