NCT01542918

Lenalidomide Plus Rituximab for Recurrent/Refractory CNS and Intraocular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: James Rubenstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I study, which means that the goal is to see if the study treatment is safe. The purpose of this study is to test the safety of Lenalidomide at different dose levels, and to test the safety of Lenalidomide alone or in combination with Rituximab (also known as Rituxan®).

Detailed description

Rationale for the Proposed Study There is evidence that immunomodulatory drugs such as lenalidomide stimulate immune effectors such as natural killer (NK) cells, and thus promote rituximab efficacy via ADCC. Because of the evidence for synergy between rituximab and lenalidomide in NHL, patients who do not respond to lenalidomide monotherapy will receive combined intravenous plus intraventricular rituximab in addition to lenalidomide. To maximize delivery to the central nervous system (CNS), the investigators propose to administer rituximab via both intravenous and intraventricular routes. The rationale for intraventricular administration of rituximab is the demonstration that approximately 0.1% of systemically administered rituximab penetrates the cerebral spinal fluid (CSF) but that intraventricular administration of rituximab is both feasible and achieves high concentrations that are associated with anti-lymphoma activity. This study will thus build upon the two Phase 1 trials of intraventricular rituximab that have been conducted at University of California, San Francisco (UCSF) to define the safety of the intraventricular route of administration; this study will, however, be the first to evaluate the combination of intraventricular plus intravenous treatment. The rationale for intravenous administration of rituximab in recurrent CNS lymphoma is that the blood-brain-barrier is likely partially disrupted, particularly when there is lymphoma-associated contrast enhancement detectable on the MRI, and the fact that there is evidence for activity when rituximab is administered intravenously, both as monotherapy (Batchelor et al., 2011) and potentially in combination with chemotherapy.

Conditions

• Recurrent/Refractory CNS
• Intraocular Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Formulation of Dosage forms: 5 mg, 10 mg, 15 mg and 25 mg capsules. Dosage: 10 mg - 30 mg (Treatment 1 and Treatment 2) Route of administration: Oral
DRUG	Rituximab	Formulation of Dosage forms: 100 mg/IO mL and 500 mg/50 mL solution in a single-use vial Dosage: 375 mg/m2, intravenous (Treatment 2, Cycle 1 only); 25 mg intraventricular injection (Treatment 2, all cycles) Route of administration: Intravenous (Treatment 2, Cycle 1 only); Intraventricular injection (Treatment 2, all cycles)

Timeline

• Start date: 2012-12-17
• Primary completion: 2016-04-07
• Completion: 2016-08-30
• First posted: 2012-03-02
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study