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OpenTrials
Completed

NCT Number: NCT01535989

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

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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Key information

Conditions

B-cell Lymphoma Refractory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oncology Institute of Southern Switzerland, Bellinzona, Canton Ticino, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inotuzumab ozogamicin

Drug

starting dose 0.8 mg/m2, d1 administration, q4wks

Other names: CMC-544

temsirolimus

Drug

starting dose of 15mg, weekly administration, q4ws

Other names: Torisel, CCI-779

Primary outcomes

  1. 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

    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 outcomes

  1. Antitumor activity based on Cheson criteria

    Time frame: after 12-18 months form the first patient in

Sponsors and collaborators

Lead sponsor

Cristiana Sessa

Other

Registry information

Official study 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

Acronym: IOSI-LND-001

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2012
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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