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IMGN529 in Combination With Rituximab in Patients With Relapsed and/or Refractory DLBCL and Other Forms of NHL

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT02564744
First received: September 11, 2015
Last updated: October 4, 2016
Last verified: October 2016
  Purpose
A Multicenter Open-Label Phase 2 Study of IMGN529 in combination with rituximab in Patients with relapsed or refractory B-Cell lymphoma and Other Forms of Non-Hodgkin's Lymphoma.

Condition Intervention Phase
Adult Diffuse Large B-Cell Lymphoma B-cell Non-Hodgkin's Lymphoma Drug: IMGN529 Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Efficacy and Tolerability of IMGN529 in Combination With Rituximab in Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: 12 months ]
  • Objective Response Rate (ORR): Number of patients with clinical responses as assessed by Lugano Classification of response assessments. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • PK parameters: maximum plasma concentration (Cmax) of IMGN529 and rituximab [ Time Frame: 12 months ]
  • PK parameters: area under the time-concentration curve (AUC) of IMGN529 and rituximab. [ Time Frame: 12 months ]
  • PK parameters: terminal half-life (t½) of IMGN529 and rituximab. [ Time Frame: 12 months ]
  • Immunogenicity: Presence of Antibody-Drug Antibody (ADA) of IMGN529 [ Time Frame: 12 months ]
  • To evaluate in terms of progression-free survival [ Time Frame: 12 months ]
  • To evaluate overall survival (OS) [ Time Frame: 12 months ]
  • To evaluate the duration of response (DOR) [ Time Frame: 12 months ]

Estimated Enrollment: 75
Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety run-in
IMGN529 + Rituximab
Drug: IMGN529 Drug: Rituximab
Experimental: Phase 2
IMGN529 + Rituximab
Drug: IMGN529 Drug: Rituximab

Detailed Description:
A Phase 2 Study to Evaluate the Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN529 in Combination with Rituximab in Patients with Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma and Other Forms of Non-Hodgkin's Lymphoma
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed relapsed and/or refractory DLBCL, FL, MZL/MALT, MCL, or other Sponsor approved NHL subtypes.
  • Patients must have evaluable or measurable disease in accordance with the International Working Group Guidelines for Lymphoma.
  • Must have received at least one but no more than six prior treatment regimens. Prior treatment with an anti-CD20 agent, either alone or in combination, is allowed.
  • Men and women ≥18 years of age
  • Patients must have ECOG Performance Status 0 - 2.
  • Patients who are HBsAg + (must be PCR negative) who are taking antivirals.

Exclusion Criteria:

  • Patients with diagnosis of CLL or small lymphocytic lymphoma (SLL).
  • Patients with active hepatitis A, B or C infection or other uncontrolled intercurrent illness.
  • Women who are pregnant or breast feeding.
  • Patients who have received prior therapy with other anti-CD37-targeting antibody drug conjugates.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02564744

Contacts
Contact: ImmunoGen Clinical 781-895-0600

Locations
United States, Illinois
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Mcfarland Clinic PC Recruiting
Ames, Iowa, United States, 50010
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Novant Health Oncology Recruiting
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Spartanburg Regional Healthcare System Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23235
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98140
Belgium
CHU UCL Namur asbl - Site Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Jan Yperman Ziekenhuis Recruiting
Ieper, West-Vlaanderen, Belgium, 8900
Switzerland
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli Recruiting
Bellinzona, Ticino, Switzerland, 6500
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Director: Anna Berkenblit ImmunoGen, Inc.
  More Information

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02564744     History of Changes
Other Study ID Numbers: IMGN0302
Study First Received: September 11, 2015
Last Updated: October 4, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 23, 2017