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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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B-cell Lymphoma Refractory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous

dose escalation

Group Type EXPERIMENTAL

Inotuzumab Ozogamicin

Intervention Type DRUG

starting dose 0.8 mg/m2, d1 administration, q4wks

Temsirolimus

Intervention Type DRUG

starting dose of 15mg, weekly administration, q4ws

Interventions

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Inotuzumab Ozogamicin

starting dose 0.8 mg/m2, d1 administration, q4wks

Intervention Type DRUG

Temsirolimus

starting dose of 15mg, weekly administration, q4ws

Intervention Type DRUG

Other Intervention Names

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CMC-544 Torisel, CCI-779

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes