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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.
 
ClinicalTrials.gov Identifier: NCT02847949
Recruitment Status : Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 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 1

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 Spectrum sponsored IGN002-101 study. If additional safety and PK data from another Spectrum sponsored 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. 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 separate study, IGN002-101, 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
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, 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 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

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 Spectrum sponsored IGN002 study, IGN002-101.
Biological: IGN002
IGN002 is a monoclonal antibody fusion protein




Primary Outcome Measures :
  1. To evaluate the 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. ]
    Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002


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. ]
    Lugano Classification Criteria for NHL will be used to assess the duration of response to IGN002

  2. Overall response rate of the therapeutic agent in NHL patients. [ Time Frame: Through study completion, an average of 1 year. ]
    Overall response rate following IGN002 treatment will be assessed



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
Criteria

Inclusion Criteria:

  1. Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101
  2. Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study
  3. Tolerated IGN002 therapy in the other Spectrum 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 other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment
  2. Experienced PD during participation in other Spectrum sponsored study, IGN002-101
  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 ClinicalTrials.gov identifier (NCT number): NCT02847949


Contacts
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Contact: Fabio Mataveli 949-743-9348 fabio.mataveli@sppirx.com
Contact: Lisia Lubiansky lisia.lubiansky@sppirx.com

Locations
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United States, California
UCLA
Santa Monica, California, United States, 90404
Contact: Nicole Sowden Williams    213-247-4788    nsowden@mednet.ucla.edu   
Principal Investigator: John Timmerman, MD         
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
The Leukemia and Lymphoma Society
Investigators
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Principal Investigator: John Timmerman University of California, Los Angeles
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02847949    
Other Study ID Numbers: IGN002-201
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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