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
  Purpose

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).


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: IMGN529
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multi-Center, Open-label Study of IMGN529 Administered Intraveneously in Adult Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Occurrence of dose limiting toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: January 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental IMGN529 Drug: IMGN529

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534715

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Arnold Freedman, MD    617-582-9086    Arnold_Freedman@dfci.harvard.edu   
Contact: Palida Noor    617-632-2368    Palida_Noor@dfci.harvard.edu   
Principal Investigator: Arnold Freedman, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: M. Lia Palomba, MD    212-639-7186    palombam@mskcc.org   
Principal Investigator: M. Lia Palomba, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Cindi Jenkins, RN, BSN    614-366-0855    cynthia.jenkins@osumc.edu   
Principal Investigator: Kami Maddocks, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jill Harrison    877-691-7274    asksarah@scresearch.net   
Contact: Meredith Zimlich    877-691-7274    asksarah@scresearch.net   
Principal Investigator: Ian Flinn, MD, PhD         
United States, Texas
CTRC at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-5798    goodwine@uthscsa.edu   
Principal Investigator: Steven Weitman, MD         
Switzerland
Oncology Institute of Southern Switzerland Recruiting
Bellinzona, Switzerland, CH-5800
Contact: Anastasios Stathis, MD       Anastasios.Stathis@eoc.ch   
Principal Investigator: Anastasios Stathis, MD         
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01534715     History of Changes
Other Study ID Numbers: IMGN0301
Study First Received: February 14, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014