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Lenalidomide Plus Rituximab for Recurrent/Refractory CNS and Intraocular Lymphoma

NCT01542918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-08-11

No results posted yet for this study

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®).

Conditions

  • Recurrent/Refractory CNS
  • Intraocular Lymphoma

Interventions

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)

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • James Rubenstein

    lead OTHER

Principal Investigators

  • James Rubenstein, MD, PhD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-17
Primary Completion
2016-04-07
Completion
2016-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542918 on ClinicalTrials.gov