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

This study is currently recruiting participants.

Verified April 2013 by ImmunoGen, Inc.

Sponsor:

Information provided by (Responsible Party):

ImmunoGen, Inc.

ClinicalTrials.gov Identifier:

NCT01534715

First received: February 14, 2012

Last updated: April 22, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 14, 2012
Last Updated Date	April 22, 2013
Start Date ^ICMJE	January 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 16, 2012)	Occurrence of dose limiting toxicities
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01534715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title ^ICMJE	A Phase I, Multi-Center, Open-label Study of IMGN529 Administered Intraveneously in Adult Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Lymphoma, Non-Hodgkin
Intervention ^ICMJE	Drug: IMGN529
Study Arm (s)	Experimental: Experimental IMGN529 Intervention: Drug: IMGN529
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	46
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States, Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01534715
Other Study ID Numbers ^ICMJE	IMGN0301
Has Data Monitoring Committee	No
Responsible Party	ImmunoGen, Inc.
Study Sponsor ^ICMJE	ImmunoGen, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ImmunoGen, Inc.
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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