NCT01664910 (Clinical Trial / inotuzumab ozogamycin / CMC-544)

Study Title

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies (NCT01664910)

Trial Description

The goal of this clinical research study is to learn which dose level of inotuzumab ozogamicin (also known as CMC-544) work best when given with fludarabine and bendamustine, with or without rituximab, before a stem cell transplant.The safety of this treatment will also be studied.

Fludarabine, bendamustine, and rituximab are commonly given before stem cell transplants. These drugs are designed to kill cancerous cells and suppress your immune system in order to lower the risk of stem cell transplant rejection. Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer coming back.

This trial is sponsored by M.D. Anderson Cancer Center/ Pfitzer. [1]

Study Data

• Condition: Lymphoma, Leukemia
• Interventions:
  • Drugs used in this trial
    • CMC-544 (inotuzumab ozogamycin)
    • Fludarabine (Fludara®; Genzyme, Inc. )
    • Bendamustine (Treanda®; Teva Pharmaceuticals)
    • Rituximab (Rituxam®; Biogen, Inc,/ Genentech, Inc.)
    • Allogeneic Stem Cell Transplantation
    • Thymoglobulin
    • Tacrolimus (Protopic®; Astellas Pharma Inc.)
    • Methotrexate (Trexall®; Teva Pharmaceuticals)
    • G-CSF
• Phase: I & II
• Estimated Enrollment: 30
• Start: October 2012
• Estimated Primary Completion: October 2017
• Last verified: June 2015

Study Schematic 

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Last Editorial review: July 31, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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