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

This study is currently recruiting participants.
Verified January 2014 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01534715
First received: February 14, 2012
Last updated: January 23, 2014
Last verified: January 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
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: Kevin Kelly, 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: January 23, 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 April 22, 2014