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A Study of IGN002 for Refractory NHL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02847949
Recruitment Status : Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : January 8, 2018
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
ImmunGene, Inc.

Brief Summary:
This is a Phase 2 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in a separate Valor study (e.g. IGN002-101) to continue treatment with IGN002. Subjects who completed a separate Valor-sponsored IGN002 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.

Condition or disease Intervention/treatment Phase
NHL Biological: IGN002 Phase 2

Detailed Description:

In this extension study, IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Valor IGN002 study (e.g., IGN002-101). If additional safety and PK data from another Valor IGN002 study support a higher dose level that is deemed safe and well tolerated by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered per Investigator discretion (see Dose Modification). Each treatment cycle comprises a total of 8 doses of IGN002 administered at weekly intervals.

Subjects will be evaluated at the study clinic before each dose of IGN002. At each study visit, standard of-care assessments will be performed, which will include physical examination, measurement of vital signs, documentation of adverse events (AEs) and concomitant medications, and laboratory analyses of blood and urine. Radiological assessments will be performed at the end of each 8-week cycle. Tumor status will be assessed by comparison to the subject's baseline tumor status, as determined in the other Valor study, or tumor nadir, if the subject has demonstrated response.

Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after the last dose of IGN002. This visit will include physical examination, vital sign measurements, laboratory analyses of blood and urine, and documentation of AEs and concomitant medications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Extension arm
IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Valor IGN002 study.
Biological: IGN002
IGN002 is a monoclonal antibody fusion protein

Primary Outcome Measures :
  1. Incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL [ Time Frame: An average of 1 year. ]

Secondary Outcome Measures :
  1. Duration of response to IGN002 using the Lugano Classification for NHL [ Time Frame: Through study completion, an average of 1 year. ]
  2. Overall response rate of the therapeutic agent in NHL patients. [ Time Frame: Through study completion, an average of 1 year. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Currently enrolled in a Valor-sponsored IGN002 study
  2. Derived clinical benefit from IGN002, defined as CR, PR, or SD, in another Valor-sponsored IGN002-101 study (e.g., IGN002-101)
  3. Tolerated IGN002 therapy in the other Valor-sponsored IGN002 study
  4. Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
  5. Able and willing to provide informed consent

Exclusion Criteria:

  1. Discontinued from another Valor IGN002 study due to an AE considered by the Investigator to be related to IGN002 treatment
  2. Experienced PD during participation in another Valor study
  3. Pregnant or nursing
  4. Concurrent medical condition that precludes safe participation in this study
  5. Active viral hepatitis infection. Subjects with history of hepatitis infection that is not active are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02847949

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Contact: Clinical Operations (877) 777-9233 ext 703

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United States, California
UCLA Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Bessie Bautista    310-570-1457   
Principal Investigator: John Timmerman, MD         
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Ashton Monismith    352-273-7832   
Principal Investigator: Nam Dang, MD         
United States, Texas
UT MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Chizobam "Chi Chi" Obi    805-300-3912   
Sponsors and Collaborators
ImmunGene, Inc.
The Leukemia and Lymphoma Society
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Study Director: Sanjay Khare, PhD ImmunGene, Inc.

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Responsible Party: ImmunGene, Inc. Identifier: NCT02847949     History of Changes
Other Study ID Numbers: IGN002-201
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No