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

June 6, 2016 updated by: Cristiana Sessa

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern
      • San Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Oncology Institute of Southern Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with adverse events based on the CTCAE v.4
Time Frame: 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
toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Antitumor activity based on Cheson criteria
Time Frame: after 12-18 months form the first patient in
after 12-18 months form the first patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristiana Sessa

Investigators

  • Principal Investigator: Anastasios Stathis, Dr., Oncology Institute of Southern Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (Estimate)

February 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOSI-LND-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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