Idelalisib Dose Optimisation Study

• Research type

  Research Study

• Full title

  Dose Optimization Study of Idelalisib in Follicular Lymphoma

• IRAS ID

  185622

• Contact name

  Silvia Montoto

• Contact email

  silvia.montoto@bartshealth.nhs.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2015-000366-66

• Clinicaltrials.gov Identifier

  101254, IND number

• Duration of Study in the UK

  3 years, 2 months, 18 days

• Research summary

  Research Summary

  Idelalisib is a medication approved by the Food and Drug Administration (FDA) in the United States and the European Union in 2014 for the treatment of relapsed Chronic Lymphocytic Leukaemia (CLL), and Follicular Lymphoma (FL). Idelalisib works by blocking certain signals that help cancer cells to grow and survive. This open-label study will evaluate the approved dosing regimen (150 twice daily) and an alternative dosing regimen, to assess whether the efficacy of the approved regimen can be confirmed and if the alternative regimen can achieve similar efficacy as the approved dosing regimen with reduced toxicity.

  Up to around 266 participants will take part in this study at 90 centres globally. Patients above the age of 18 with a confirmed diagnosis of FL will be eligible.

  Participants will be randomised to a dosing regimen of 150 mg twice daily (Arm A) or a 28 day cycle regimen of 21 days on150 mg twice daily, followed by 7 days off-treatment (Arm B). The 100mg twice daily arm (Arm B) of the study is now closed to recruitment as per the new protocol amendment. . Participants already enrolled onto the study will remain on the same dosing regimen they were assigned (which was double blinded). New participants will be enrolled in an open-label fashion.
  
  Participants will continue to receive idelalisib until the earliest of: their disease worsening, unacceptable side effects, pregnancy, substantial noncompliance with study procedures or study medication, initiation of another anti-cancer or experimental therapy, study discontinuation, or withdrawal from study.

  Participants will undergo various assessments during the study including blood sampling, physical exams, Electrocardiogram, CT/PET-CT/MRI Scans and Bone Marrow Biopsies.

  Summary of Results:
  Of the 145 participants screened, 96 participants were randomised to the study. Of these, 95 participants received at least 1 dose of study drug (IDL) and were included in the Safety Analysis Set. All the 96 participants (100%) discontinued the study drug (only 95 participants had received at least 1 dose of study drug) and the study.

  Of the 95 participants that received the study drug, 37% (35 participants) experienced grade 4 or higher medical events. With regards to overall side effects, 32% (30 participants) experienced serious side effects, 78% (74 participants) experienced any side effect, 1% (1 participant) died from a side effect and 39% (37 participants) discontinued from study treatment due to side effects.

  The most common serious side effects were: diarrhoea with 13% of participants experiencing this, swelling and irritation of the large intestine with 3% of participants experiencing this side effect, lung infection which effected 3% of participants, Fever with a low number of white blood cells with 2% of participants experiencing this side effect and Liver damage caused by drugs, poisons, or chemicals impacting 2% of participants.

  The top 8 most common side effects that occurred during the study were: diarrhoea with 29% of participants experiencing this, low number of white blood cells with 22% of participants experiencing this side effect, Increased level of liver protein in the blood (alanine aminotransferase increased) and rash which effected 15% participants, Increased level of liver protein in the blood (aspartate aminotransferase increased) with 14% of participants experiencing this side effect, fever impacting 7% of participants, Swelling and irritation of the large intestine and Lung infection with 5% of participants experiencing these side effects.

  This summary shows only the main results from this one study. You can find more information about this study on the websites listed below.

  www.Clinicaltrials.gov and search NCT02536300
  www.Clinicaltrialsregister.eu and search 2015-000366-66
  www.Gileadclinicaltrials.com and search GS-US-313-1580

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  15/YH/0434

• Date of REC Opinion

  21 Oct 2015

• REC opinion

  Further Information Favourable Opinion