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.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | — |