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Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma

NCT02898259 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-09-26

Study results available
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Summary

A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B cell Lymphoma

Conditions

Interventions

DRUG

Ixazomib

The prescribed administration of ixazomib doses in this study is 2.0, 3.0 or 4.0 mg ixazomib on days 1, 8 and 15 of each 28 day cycle.

DRUG

Lenalidomide

Lenalidomide starting dose will be based on baseline calculated creatinine clearance as follows: * Starting lenalidomide Dose (20mg) * Calculated Creatinine Clearance: \>=60ml/min receive 20 mg daily on Days 1 - 21 of each 28-day cycle * Calculated Creatinine Clearance: \>= 30 and \< 60 ml/min receive 10 mg daily on Days 1 - 21 of each 28-day cycle

DRUG

Rituximab

Rituximab is administered intravenously at 375mg/m2 on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6 and day 1 of cycles 8, 10, and 12.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Brian Hill

    lead OTHER

Principal Investigators

  • Brian Hill, MD, PhD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2018-10-23
Completion
2022-06-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02898259 on ClinicalTrials.gov