IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01534715
First received: February 14, 2012
Last updated: May 16, 2014
Last verified: May 2014

February 14, 2012
May 16, 2014
January 2012
December 2015   (final data collection date for primary outcome measure)
Occurrence of dose limiting toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
Occurrence of dose limiting toxicities
Complete list of historical versions of study NCT01534715 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I, Multi-Center, Open-label Study of IMGN529 Administered Intraveneously in Adult Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL).

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
Drug: IMGN529
Experimental: Experimental IMGN529
Intervention: Drug: IMGN529
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
Not Provided
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL).
  • Adequate organ function
  • ECOG ≤ 2
  • Recovered or stabilized from prior treatments.

Exclusion Criteria:

  • Allogeneic stem cell transplantation
  • Pregnant or lactating females
  • Known central nervous system, meningeal or epidural disease including brain metastases
Both
18 Years and older
No
United States,   Switzerland
 
NCT01534715
IMGN0301
No
ImmunoGen, Inc.
ImmunoGen, Inc.
Not Provided
Not Provided
ImmunoGen, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP