Mechanisms of Idelalisib-Associated Diarrhea in Patients With Relapsed Chronic Lymphocytic Leukemia, Indolent Non-hodgkin Lymphoma, or Small Lymphocytic Lymphoma
NCT ID: NCT02928510
Last Updated: 2021-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
1 participants
OBSERVATIONAL
2016-02-01
2018-06-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma
NCT01644799
Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
NCT01088048
Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant
NCT02662296
Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
NCT01393106
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
NCT01955499
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To explore the cellular and molecular mechanisms of idelalisib-induced diarrhea/colitis in relapsed chronic lymphocytic leukemia (CLL), relapsed indolent non-hodgkin lymphomas (iNHL), or relapsed small lymphocytic lymphoma (SLL).
II. To further understand the mechanism of action (MOA) of idelalisib in context of the nodal microenvironment and the possible involvement of the immune system in idelalisib's anti-lymphoma activity.
OUTLINE:
Patients receive a physical examination during visit 1. A stool sample, blood sample, and 6 biopsies are collected at visit 2, and patients undergo a flexible fiberoptic sigmoidoscopy. Patients receive idelalisib orally (PO) twice daily (BID) after visit 2. Treatment continues in the absence of disease progression or unacceptable toxicity. A third research visit occurs upon development of idelalisib-associated diarrhea/colitis symptoms. Patients with diarrhea/colitis symptoms undergo a full colonoscopy and collection of stool and blood samples. Control patients with no diarrhea/colitis symptoms undergo all needed tests and assessments including a flexible fiberoptic sigmoidoscopy and collection of stool and blood samples. All patients undergo optional biospecimen collection at the time of disease progression.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Basic Science (biospecimen collection, idelalisib)
Patients receive a physical examination during visit 1. A stool sample, blood sample, and 6 biopsies are collected at visit 2, and patients undergo a flexible fiberoptic sigmoidoscopy. Patients receive idelalisib PO twice daily BID after visit 2. Treatment continues in the absence of disease progression or unacceptable toxicity. A third research visit occurs upon development of idelalisib-associated diarrhea/colitis symptoms. Patients with diarrhea/colitis symptoms undergo a full colonoscopy and collection of stool and blood samples. Control patients with no diarrhea/colitis symptoms undergo all needed tests and assessments including a flexible fiberoptic sigmoidoscopy and collection of stool and blood samples. All patients undergo optional biospecimen collection at the time of disease progression.
Biospecimen Collection
Undergo biospecimen collection
Colonoscopy
Undergo colonoscopy
Colposcopic Biopsy
Undergo colposcopic biopsy
Idelalisib
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Physical Examination
Undergo physical examination
Sigmoidoscopy
Undergo sigmoidoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo biospecimen collection
Colonoscopy
Undergo colonoscopy
Colposcopic Biopsy
Undergo colposcopic biopsy
Idelalisib
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Physical Examination
Undergo physical examination
Sigmoidoscopy
Undergo sigmoidoscopy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For iNHL: measureable nodal disease, defined as the presence of \>= 1 nodal lesion that measures \>= 2 cm in a single dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
* Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL \>= 3 weeks before initiation of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Absolute neutrophil count \> 750
* Platelets \> 50,000
* Total bilirubin \< 2 X institutional upper limit of normal (ULN)
* Aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/ alanine transferase (ALT) serum glutamate pyruvate transaminase (SPGT) \< 3 X institutional ULN
* Creatinine \< 2 X institutional ULN
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent; all patients must have signed, witnessed informed consent prior to registration
Exclusion Criteria
* Known histological transformation from iNHL to diffuse large B-cell lymphoma or Richter's Transformation for CLL
* Ongoing treatment with any other investigational agents
* Known central nervous system (CNS) involvement of lymphoma (CNS staging not required)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to idelalisib
* Uncontrolled inter-current illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Known human immunodeficiency virus (HIV) infection (HIV testing not required)
* Known John Cunningham (JC) virus infection and/or progressive multifocal leukoencephalopathy (PML)
* Clinically active hepatitis A, B, or C infections
* NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy for the duration of enrollment in the trial
* Pregnancy or active nursing of an infant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Hommes
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-01002
Identifier Type: REGISTRY
Identifier Source: secondary_id
15-001217
Identifier Type: OTHER
Identifier Source: secondary_id
15-001217
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.