← Back to Search

Idelalisib 100 MG for Mantle Cell Lymphoma

Phase 1
Waitlist Available
Led By Douglas Gladstone, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance score ≥ 40
>18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning day 90 post transplant until day 360
Awards & highlights

Study Summary

This trial will evaluate the safety of idelalisib when used as post-transplantation maintenance in patients with blood cancer who have undergone a stem cell transplant from another person.

Eligible Conditions
  • Mantle Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • B-Cell Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning day 90 post transplant until day 360
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning day 90 post transplant until day 360 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.
Secondary outcome measures
Event Free Survival at One Year.
Identify Potential Predictive Biomarker Candidates Based on Exploratory Gene Expression Analysis of Immune Biomarkers in Bone Marrow Aspirates and Whole or Targeted Exome Sequencing of Lymphoma Cells

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Idelalisib 100mgExperimental Treatment1 Intervention
Idelalisib is an orally-administered, selective inhibitor of Phosphoinositide 3 kinase (PI3K)-delta which has been shown to be extremely effective in inducing partial to complete responses in many B-cell derived malignancies. intervention: 100mg Idelalisib twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant
Group II: Placebo oral tabletPlacebo Group1 Intervention
Placebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,850 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,081 Previous Clinical Trials
842,685 Total Patients Enrolled
Douglas Gladstone, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 Previous Clinical Trials
86 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
Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies
2018. "Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03151057.
~2 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