To be eligible for the INDIGO Study, participants must meet certain criteria. If you think you might be eligible, your doctor can help you review all of the eligibility requirements, including the key requirements set out below.

Key Eligibility Requirements1

  1. Be at least 12 years old
  2. Have Grade 2 oligodendroglioma or astrocytoma (low-grade glioma)
  3. Do not have a need for immediate chemotherapy or radiation
  4. Have an IDH1 or IDH2 gene-mutated disease (IDH mutation occur in about 70-80% of Grade 2 gliomas2)
  5. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection). The most recent surgery must have occurred at least 1 year and not more than 5 years prior to the study
  6. Have had no prior anti-cancer therapy other than surgery for treatment of glioma, including chemotherapy or radiation
  7. Be able to carry on normal activity and to work with no special care needed, even if it is with some effort and signs or symptoms of the disease3
  8. Measure at specific levels that demonstrate adequate bone marrow function, hepatic (liver) function, and renal (kidney) function
  9. Are not taking lamotrigine as an anti-seizure medication
  10. Do not have a known active Hepatitis B (HBV) or Hepatitis C (HCV) infection, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS)-related illness. Patients with a sustained viral response to HCV treatment or immunity to prior HBV infection will be allowed to participate. Patients with chronic HBV that is adequately suppressed by institutional practice will be also be permitted.

How to Participate

To learn where the current INDIGO Study sites are and how you can participate, please see the Study Site Locator.

What Should I Expect if I Participate?

If you think you might be eligible for the INDIGO Study, learn more about what to expect during the study

Learn what to expect

What are my next steps?

If you are ready to discuss the INDIGO Study with your doctor, this Doctor Discussion Guide can help inform your conversation.

Download Guide
Disclaimer

The effectiveness and safety of vorasidenib have not been established. There is no guarantee that vorasidenib will receive health authority approval or become commercially available in any country for the use being investigated.

References

  1. Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) – https://clinicaltrials.gov/ct2/show/NCT04164901
  2. Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 Mutations in Gliomas. N Engl J Med 2009;
    360:765-773.
  3. Karnofsky Performance Status Scale Definitions Rating (%) Criteria. National Palliative Care
    Research Center. http://www.npcrc.org/files/news/karnofsky_performance_scale.pdf. Accessed August 23, 2019