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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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B-cell Lymphoma Refractory

Intervention / Treatment
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* Drug: Inotuzumab Ozogamicin
* Drug: Temsirolimus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous<br>dose escalation | Drug: Inotuzumab Ozogamicin<br>* starting dose 0.8 mg/m2, d1 administration, q4wks<br>* Other names: CMC-544;Drug: Temsirolimus<br>* starting dose of 15mg, weekly administration, q4ws<br>* Other names: Torisel, CCI-779;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell Non Hodgkin's Lymphomas, CD22 positive