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

Sponsor

Cristiana Sessa (Other)

Overall Status

Completed

CT.gov ID

NCT01535989

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Lymphoma Refractory	Drug: Inotuzumab Ozogamicin Drug: Temsirolimus	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intravenous dose escalation	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

Arm

Intervention/Treatment

Experimental: intravenous

dose escalation

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

Outcome Measures

Primary Outcome Measures

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

Antitumor activity based on Cheson criteria [after 12-18 months form the first patient in]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Institute of Southern Switzerland	Bellinzona	Ticino	Switzerland	6500
2	InselSpital, Universitätsspital Bern	Bern		Switzerland	3010
3	Kantonsspital St.Gallen	San Gallen		Switzerland	9007