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NCT01535989 (Clinical Trial / inotuzumab ozogamycin / CMC-544)

Study Title

Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma (IOSI-LND-001) (NCT01535989)

Trial Description
This is an open label phase I study of Inotuzumab Ozogamicin (also known as CMC-544) , an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non Hodgkin’s lymphomas (NHLs).

Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs. This is the first study combining the two agents together. In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated every 28 days.

This trial is sponsored by Cristiana Sessa, Oncology Institute of Southern Switzerland  [1]

Study Data

  • Condition: B-Cell Lymphoma
  • Interventions:
  • Phase: I
  • Estimated Enrollment: 25
  • Start: December 2011
  • Estimated Completion: December 2015
  • Last verified: February 2015

Study Schematic 

NCT01535989 (CLINICAL TRIAL / INOTUZUMAB OZOGAMYCIN / CMC-544)

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

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