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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oncology Institute of Southern Switzerland
Sponsor:
Information provided by (Responsible Party):
Cristiana Sessa, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier:
NCT01535989
First received: January 27, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
B-cell Lymphoma Refractory
Drug: Inotuzumab Ozogamicin
Drug: Temsirolimus
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oncology Institute of Southern Switzerland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: after 12-18 months form the first patient in ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intravenous
dose escalation
Drug: Inotuzumab Ozogamicin
starting dose 0.8 mg/m2, d1 administration, q4wks
Other Name: CMC-544
Drug: Temsirolimus
starting dose of 15mg, weekly administration, q4ws
Other Name: Torisel, CCI-779

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535989

Contacts
Contact: Anastasios Stathis, Dr. +41918118931 anastasios.stathis@eoc.ch
Contact: Tatiana Terrot +41918119183 tatiana.terrot@eoc.ch

Locations
Switzerland
Dr. Anastasios Stathis Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Anastasios Stathis, Dr    +41918118931    anastasios.stathis@eoc.ch   
Principal Investigator: Anastasios Stathis, Dr.         
Dr. Urban Novak Recruiting
Bern, Switzerland, 3010
Contact: Urban Novak, MD    +41316321992    urban.novak@insel.ch   
Principal Investigator: Urban Novak, MD         
Dr. Felicitas Hitz Recruiting
San Gallen, Switzerland, 9007
Contact: Felicitas Hitz, Dr    +41714941111    felicitas.hitz@kssg.ch   
Principal Investigator: Felicitas Hitz, Dr         
Sponsors and Collaborators
Cristiana Sessa
Investigators
Principal Investigator: Anastasios Stathis, Dr. Oncology Institute of Southern Switzerland
  More Information

No publications provided

Responsible Party: Cristiana Sessa, Prof., Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT01535989     History of Changes
Other Study ID Numbers: IOSI-LND-001
Study First Received: January 27, 2012
Last Updated: April 9, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Oncology Institute of Southern Switzerland:
B-cell Non Hodgkin's Lymphomas
CD22 positive

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014