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NCT01534715 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01534715
Other study ID # IMGN0301
Secondary ID
Status Completed
Phase Phase 1
First received February 14, 2012
Last updated December 27, 2017
Start date January 2012
Est. completion date July 2016

Study information
Verified date August 2016
Source ImmunoGen, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) and Chronic Lymphocytic Leukemia (CLL).

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IMGN529

Locations
Country Name City State
Switzerland Oncology Institute of Southern Switzerland Bellinzona
United States Dana Farber Cancer Institute Boston Massachusetts
United States Ohio State University Columbus Ohio
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Sarah Cannon Research Institute Nashville Tennessee
United States Memorial Sloan-Kettering Cancer Center New York New York
United States CTRC at UTHSCSA San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
ImmunoGen, Inc.

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of dose limiting toxicities During study
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