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

Primary Purpose

B-cell Lymphoma Refractory

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Inotuzumab Ozogamicin
Temsirolimus
Sponsored by
Cristiana Sessa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Lymphoma Refractory focused on measuring B-cell Non Hodgkin's Lymphomas, CD22 positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oncology Institute of Southern Switzerland
  • InselSpital, Universitätsspital Bern
  • Kantonsspital St.Gallen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravenous

Arm Description

dose escalation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Antitumor activity based on Cheson criteria

Full Information

First Posted
January 27, 2012
Last Updated
June 6, 2016
Sponsor
Cristiana Sessa
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1. Study Identification

Unique Protocol Identification Number
NCT01535989
Brief Title
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristiana Sessa

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma Refractory
Keywords
B-cell Non Hodgkin's Lymphomas, CD22 positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravenous
Arm Type
Experimental
Arm Description
dose escalation
Intervention Type
Drug
Intervention Name(s)
Inotuzumab Ozogamicin
Other Intervention Name(s)
CMC-544
Intervention Description
starting dose 0.8 mg/m2, d1 administration, q4wks
Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Other Intervention Name(s)
Torisel, CCI-779
Intervention Description
starting dose of 15mg, weekly administration, q4ws
Primary Outcome Measure Information:
Title
number of participants with adverse events based on the CTCAE v.4
Description
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
Time Frame
toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
Antitumor activity based on Cheson criteria
Time Frame
after 12-18 months form the first patient in

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios Stathis, Dr.
Organizational Affiliation
Oncology Institute of Southern Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
InselSpital, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
San Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34407735
Citation
Pirosa MC, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma. 2022 Jan;63(1):117-123. doi: 10.1080/10428194.2021.1966780. Epub 2021 Aug 19.
Results Reference
derived

Learn more about this trial

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

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