NCT01535989

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

4.5 years

First QC Date

January 27, 2012

Last Update Submit

June 6, 2016

Conditions

B-cell Lymphoma Refractory

Keywords

B-cell Non Hodgkin's LymphomasCD22 positive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Antitumor activity based on Cheson criteria

    after 12-18 months form the first patient in

Study Arms (1)

intravenous

EXPERIMENTAL

dose escalation

Drug: Inotuzumab OzogamicinDrug: Temsirolimus

Interventions

Inotuzumab OzogamicinDRUG

starting dose 0.8 mg/m2, d1 administration, q4wks

Also known as: CMC-544
intravenous
TemsirolimusDRUG

starting dose of 15mg, weekly administration, q4ws

Also known as: Torisel, CCI-779
intravenous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled intercurrent illness
  • Chronic obstructive or chronic restrictive pulmonary disease
  • Hepatitis B, C and HIV
  • Patients with known known central nervous system lymphoma involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

InselSpital, Universitätsspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Kantonsspital St.Gallen

San Gallen, San Gallen, 9007, Switzerland

Location

Related Publications (1)

  • Pirosa MC, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma. 2022 Jan;63(1):117-123. doi: 10.1080/10428194.2021.1966780. Epub 2021 Aug 19.

    PMID: 34407735DERIVED

MeSH Terms

Interventions

Inotuzumab Ozogamicintemsirolimus

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anastasios Stathis, Dr.

    Oncology Institute of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 20, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

CH(3)