CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 79 enrolled
Drug / intervention
Inotuzumab ozogamicin [CMC-544]drug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓CD22-positive, B-cell NHL (WHO classification) that has progressed after at least 2 prior therapies of probable clinical benefit
  • ✓Age 18 years or older
  • ✓At expanded cohort (part 2): Follicular lymphoma previously treated with at least one dose of rituximab, or DLBCL
Key exclusion· 3
  • ✕Candidate for potentially curative therapies in the opinion of the investigator
  • ✕Chronic lymphocytic leukemia
  • ✕Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma

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

Search/NCT00073749
NCT00073749Phase 1Completed
CompareCT.gov

A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma

Pfizer·interventional·Posted Dec 5, 2003·Updated Dec 17, 2018

In Brief

A Phase 1 clinical trial evaluating Inotuzumab ozogamicin [CMC-544] for Lymphoma, B-Cell. Completed, enrolled 79 participants across 22 sites in 7 countries.

Detailed Summary

To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesBelgium, France, Germany, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2003
Enrollment StartAug 1, 2003
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 22.6 years ago

Interventions

Inotuzumab ozogamicin [CMC-544]drug

CMC-544, IV, dose escalation trial