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:
ImmunoGen, Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
| Estimated Enrollment: | 46 |
| Study Start Date: | January 2012 |
| 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, 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 | |
| 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: | April 22, 2013 |
| 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 May 16, 2013