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

B-cell Lymphoma Refractory Clinical Trial

— IOSI-LND-001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535989
• Other study ID #: IOSI-LND-001
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2012
• Last updated: June 6, 2016
• Start date: December 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Lymphoma Refractory
• Lymphoma, B-Cell

Intervention

Drug:
• Inotuzumab Ozogamicin
starting dose 0.8 mg/m2, d1 administration, q4wks
• Temsirolimus
starting dose of 15mg, weekly administration, q4ws

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona	Ticino
Switzerland	InselSpital, Universitätsspital Bern	Bern
Switzerland	Kantonsspital St.Gallen	San Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cristiana Sessa

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with adverse events based on the CTCAE v.4	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	toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks	Yes
Secondary	Antitumor activity based on Cheson criteria		after 12-18 months form the first patient in	No