Trial | NCT01535989  Report issue

Title

Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
A Phase I Study of Inotuzumab Ozogamicin (CMC-544) in Combination With Temsirolimus (CCI-779) in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkin's Lymphomas

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    25
This is an open label phase I study of Inotuzumab Ozogamicin, 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.
Study Started
Dec 31
2011
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jun 07
2016
Estimate

Drug Inotuzumab Ozogamicin

starting dose 0.8 mg/m2, d1 administration, q4wks

  • Other names: CMC-544

Drug Temsirolimus

starting dose of 15mg, weekly administration, q4ws

  • Other names: Torisel, CCI-779

intravenous Experimental

dose escalation

Criteria 

Key inclusion criteria

Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non Hodgkin's Lymphomas
No limitations on prior treatments. Patients must have progressed after at least one prior therapy.
Adult patients (aged > 18yrs old).
ECOG status ≤ 1.
Life expectancy greater than 3 months.
Adequate organ and marrow function.

Key exclusion criteria

Uncontrolled intercurrent illness
Chronic obstructive or chronic restrictive pulmonary disease
Hepatitis B, C and HIV
Patients with known known central nervous system lymphoma involvement.
No Results Posted