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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
B-cell Lymphoma Refractory

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of participants with adverse events based on the CTCAE v.4

Outcome Description:

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

Outcome Time Frame:

toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks

Safety Issue:

Yes

Principal Investigator

Anastasios Stathis, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Institute of Southern Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

IOSI-LND-001

NCT ID:

NCT01535989

Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • B-cell Lymphoma Refractory
  • B-cell Non Hodgkin's Lymphomas
  • CD22 positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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