Lenalidomide Plus Rituximab for Recurrent/Refractory CNS and Intraocular Lymphoma

Conditions

• Intraocular Lymphoma
• Recurrent/Refractory CNS

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lenalidomide — DRUG
  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
• Rituximab — DRUG
  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)

Study Details

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®).

Key Dates

Start date

Dec 17, 2012

Status verified

Aug 2020

Primary completion

Apr 7, 2016

Completion

Aug 30, 2016

Study Design

Enrollment

14 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Study intervention
  Lenalidomide Plus Rituximab

Primary Outcome Measure

To establish the maximal tolerated dose (MTD) of Lenalidomide in patients with recurrent CNS NHL and intraocular NHL [ Time Frame: Participants will be followed for the duration of treatment, an expected average of 4 months. ]

Locations (1)

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