A Study of IGN002 for Refractory NHL
Withdrawn before enrolling · Phase 1
Conditions studied: NHL
In brief
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.
Key facts
- Study ID
- NCT02847949
- Run by
- Spectrum Pharmaceuticals, Inc
- People needed
- 0
- Starts
- 2021-01-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2022-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101
- Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study
- Tolerated IGN002 therapy in the other Spectrum sponsored IGN002 study
- 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.
- Able and willing to provide informed consent
You may not qualify if…
- Discontinued from other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment
- Experienced PD during participation in other Spectrum sponsored study, IGN002-101
- Pregnant or nursing
- Concurrent medical condition that precludes safe participation in this study
- Active viral hepatitis infection. Subjects with history of hepatitis infection that is not active are eligible.
Where it is running
- UCLA — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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