Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma

Phase 1

Completed

• Conditions: B-cell Lymphoma Refractory
• Interventions: Drug: Inotuzumab Ozogamicin; Drug: Temsirolimus

• Registration Number: NCT01535989
• Lead Sponsor: Cristiana Sessa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous	Temsirolimus	dose escalation
intravenous	Inotuzumab Ozogamicin	dose escalation

Primary Outcome Measures

Name	Time	Method
number of participants with adverse events based on the CTCAE v.4	toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks	To determine the safety profile, establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Inotuzumab Ozogamicin in combination with Temsirolimus in patients with relapsed/refractory CD22+ B-cell NHLs

Secondary Outcome Measures

Name	Time	Method
Antitumor activity based on Cheson criteria	after 12-18 months form the first patient in

Trial Locations

Locations (3)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Ticino, Switzerland

InselSpital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital St.Gallen; 🇨🇭 San Gallen, Switzerland