drugset / 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.

NCT01848652 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-10
Primary completion
2015-05
Completion
2015-05

Outcome

Outcome not reported

Stopped (Enrollment): “The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 50 mg/m2 —

Indications