Back to resultsIMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Primary Purpose
Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMGN529
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin
Eligibility 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
Sites / Locations
- Dana Farber Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- Ohio State University
- Sarah Cannon Research Institute
- CTRC at UTHSCSA
- Medical College of Wisconsin
- Oncology Institute of Southern Switzerland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMGN529
Arm Description
Dose escalation study, dosing done every 3 weeks.
Outcomes
Primary Outcome Measures
Occurrence of dose limiting toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01534715
Brief Title
IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMGN529
Arm Type
Experimental
Arm Description
Dose escalation study, dosing done every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
IMGN529
Primary Outcome Measure Information:
Title
Occurrence of dose limiting toxicities
Time Frame
During study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
CTRC at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-5800
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
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