Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma (IOSI-LND-001)
This study is currently recruiting participants.
Verified January 2013 by Oncology Institute of Southern Switzerland
Sponsor:
Cristiana Sessa
Information provided by (Responsible Party):
Cristiana Sessa, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier:
NCT01535989
First received: January 27, 2012
Last updated: January 10, 2013
Last verified: January 2013
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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. 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: | January 10, 2013 |
| 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 Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013