← Back to Search

PI3K Inhibitor

Idelalisib for Follicular Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to end of treatment (maximum duration: 73.5 months)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating people with a certain type of lymphoma who have no other options.

Eligible Conditions
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to end of treatment (maximum duration: 73.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to end of treatment (maximum duration: 73.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
+6 more

Side effects data

From 2019 Phase 3 trial • 416 Patients • NCT01569295
62%
Neutropenia
43%
Diarrhoea
38%
Pyrexia
29%
Nausea
26%
Anaemia
25%
Cough
22%
Fatigue
22%
Febrile neutropenia
20%
Thrombocytopenia
18%
Upper respiratory tract infection
18%
Pneumonia
17%
Vomiting
17%
Rash
15%
Constipation
15%
Alanine aminotransferase increased
14%
Infusion related reaction
13%
Arthralgia
12%
Asthenia
12%
Weight decreased
12%
Decreased appetite
11%
Chills
10%
Bronchitis
10%
Abdominal pain
10%
Hypokalaemia
10%
Headache
10%
Dyspnoea
9%
Aspartate aminotransferase increased
9%
Night sweats
9%
Sinusitis
9%
Insomnia
8%
Back pain
8%
Nasopharyngitis
8%
Pruritus
8%
Leukopenia
8%
Oedema peripheral
8%
Productive cough
7%
Hypotension
7%
Dyspepsia
6%
Hypogammaglobulinaemia
6%
Hypertension
6%
Lower respiratory tract infection
5%
Sepsis
5%
Herpes zoster
5%
Oropharyngeal pain
3%
Urinary tract infection
3%
Respiratory tract infection
3%
Anxiety
2%
Colitis
2%
Cellulitis
2%
Septic shock
2%
Pneumonitis
2%
Myelodysplastic syndrome
1%
Hyponatraemia
1%
Influenza
1%
Escherichia sepsis
1%
Basal cell carcinoma
1%
Ophthalmic herpes zoster
1%
Pancreatitis
1%
Neutropenic sepsis
1%
Device related infection
1%
Gastroenteritis
1%
Pneumonia pseudomonal
1%
Pulmonary embolism
1%
Renal colic
1%
Pneumocystis jirovecii pneumonia
1%
Prostate cancer
1%
Squamous cell carcinoma of skin
1%
Hypoxia
1%
Tumour lysis syndrome
1%
Stevens-Johnson syndrome
1%
Pleural effusion
1%
Respiratory failure
1%
Hepatocellular injury
1%
Hypersensitivity
1%
Cytomegalovirus infection
1%
Urosepsis
1%
Malignant melanoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Idelalisib + Bendamustine + Rituximab
Placebo + Bendamustine + Rituximab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Idelalisib 150 mg BID INTExperimental Treatment1 Intervention
Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment.
Group II: Idelalisib 150 mg BIDExperimental Treatment1 Intervention
Participants will receive idelalisib 150 mg twice daily continuously. For participants enrolled prior to protocol amendment 5: Based on the independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily.
Group III: Idelalisib 100 mg BIDExperimental Treatment1 Intervention
Participants will receive idelalisib 100 mg twice daily continuously. Based on the IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily. As of protocol amendment 5, enrollment to this arm has been closed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idelalisib
2017
Completed Phase 3
~1660

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,745 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,739 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose Optimization Study of Idelalisib in Follicular Lymphoma
2016. "Dose Optimization Study of Idelalisib in Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02536300.
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top