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

NCT ID: NCT01534715

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMGN529

Dose escalation study, dosing done every 3 weeks.

Group Type EXPERIMENTAL

IMGN529

Intervention Type DRUG

Interventions

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IMGN529

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ImmunoGen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

CTRC at UTHSCSA

San Antonio, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Oncology Institute of Southern Switzerland

Bellinzona, , Switzerland

Site Status

Countries

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United States Switzerland

Other Identifiers

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IMGN0301

Identifier Type: -

Identifier Source: org_study_id