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

• Sponsor: ImmunoGen, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01534715
• Collaborator: (none)
• Enrollment: 49
• Locations: 7
• Arm: 1
• Duration (Months): 54
• Patients Per Site: 7
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin; Chronic Lymphocytic Leukemia	Drug: IMGN529	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMGN529 Dose escalation study, dosing done every 3 weeks.	Drug: IMGN529

Outcome Measures

Primary Outcome Measures

1. Occurrence of dose limiting toxicities [During study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
3	Ohio State University	Columbus	Ohio	United States	43210
4	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
5	CTRC at UTHSCSA	San Antonio	Texas	United States	78229
6	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
7	Oncology Institute of Southern Switzerland	Bellinzona		Switzerland	CH-5800

Sponsors and Collaborators

• ImmunoGen, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ImmunoGen, Inc.
• ClinicalTrials.gov Identifier: NCT01534715
• Other Study ID Numbers: IMGN0301
• First Posted: Feb 17, 2012
• Last Update Posted: Dec 29, 2017
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Dec 29, 2017