CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
MEDI-551 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00983619
NCT00983619Phase 2Completed
CompareCT.gov

A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies

MedImmune LLC·interventional·Posted Sep 24, 2009·Updated May 13, 2020

In Brief

A Phase 2 clinical trial evaluating MEDI-551 and Rituximab for B-cell Malignancies and Cancer. Completed, enrolled 136 participants across 21 sites in 5 countries.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Malignancies, Cancer
CountriesBelgium, Canada, Italy, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2009
Enrollment StartApr 16, 2010
Primary CompletionMar 21, 2019
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 16.8 years ago

Interventions

MEDI-551drug

MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.

Rituximabdrug

Rituximab will be administered IV on Days 1, 8, 15, and 22 (28- day cycle). The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent.