NCT01534715

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 29, 2017

Status Verified

August 1, 2016

Enrollment Period

4.5 years

First QC Date

February 14, 2012

Last Update Submit

December 27, 2017

Conditions

Lymphoma, Non-HodgkinChronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of dose limiting toxicities

    During study

Study Arms (1)

IMGN529

EXPERIMENTAL

Dose escalation study, dosing done every 3 weeks.

Drug: IMGN529

Interventions

IMGN529DRUG
IMGN529

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Allogeneic stem cell transplantation
  • Pregnant or lactating females
  • Known central nervous system, meningeal or epidural disease including brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

CTRC at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-5800, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

naratuximab emtansine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 29, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(6)CH(1)