Trial intelligence / Profile preview

Inotuzumab Ozogamicin with FBR Conditioning for Allo-SCT in Lymphoid Malignancies

NCT01664910Phase 2

Key facts

Status
Completed
Start
Oct 2012
Primary completion
Jun 2023
Countries
1
Sponsor
University of Texas MD Anderson Cancer Center
Modality
Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
Conditions
lymphoid malignancy
01

Overview

Phase 2, open-label, single-arm trial of inotuzumab ozogamicin in lymphoid malignancy, sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Maximum-tolerated Dose of Inotuzumab Without DLT at 30 days. Started Oct 2012; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Treatment (transplant)

    Inotuzumab ozogamicin + FBR conditioning followed by Allo-SCT

03

Endpoints

Primary

  • Maximum-tolerated Dose of Inotuzumab Without DLT

Secondary

  • Overall Response

  • Overall Survival

  • Event-Free Survival

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