IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01534715
First received: February 14, 2012
Last updated: July 13, 2015
Last verified: July 2015
  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) and Chronic Lymphocytic Leukemia (CLL).


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Chronic Lymphocytic Leukemia
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 Intravenously in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

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: 110
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), chronic lymphocytic leukemia (CLL).
  • 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: Brendan Toohey, MD    617-632-2368    btoohey1@partners.org   
Principal Investigator: Arnold Freedman, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Rebecca Green    646-449-1312    borsukr@mskcc.org   
Principal Investigator: M. Lia Palomba, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Misty Flemming    614-688-9498    misty.flemming@osumc.edu   
Principal Investigator: Kami Maddocks, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Katie Rice    615-329-7274    katie.rice@scresearch.net   
Principal Investigator: Ian Flinn, MD, PhD         
United States, Texas
CTRC at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact: Kathleen Cobb    210-450-5893    cobb@uthscsa.edu   
Principal Investigator: Steven Weitman, MD         
Switzerland
Oncology Institute of Southern Switzerland Recruiting
Bellinzona, Switzerland, CH-5800
Contact: Sheila Gaggetta, MD    +41918118215    Sheila.Gaggetta@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: July 13, 2015
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 01, 2015