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Absence of Signs or SymptomsNCT02928510

Mechanisms of Idelalisib-Associated Diarrhea in Patients With Relapsed Chronic Lymphocytic Leukemia, Indolent Non-hodgkin Lymphoma, or Small Lymphocytic Lymphoma

An observational study of Absence of Signs or Symptoms and B-Cell Non-Hodgkin Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research trial studies the mechanisms of idelalisib-associated diarrhea in patients with chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, or small lymphocytic lymphoma that has come back after a period of improvement. The cancer treatment drug idelalisib triggers diarrhea in some patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Colonoscopy and Colposcopic Biopsy
Type of treatment
Surgery or procedure
How many people
1 participants
Where
1 siteUnited States
Study dates
1 Feb 2016to 5 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients suffering from relapsed chronic lymphocytic leukemia (CLL), relapsed indolent Non-Hodgkin lymphomas (iNHL), or relapsed small lymphocytic lymphoma (SLL) will be enrolled in the UCLA Lymphoma Program and they will be receiving Idelalisib/Zydelig as the standard care treatment are potentially eligible for this specimen collection study.

Who may be able to join

  • Food and Drug Administration (FDA)-approved indications for idelalisib of relapsed, histologically confirmed B-cell indolent non-hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL)
  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Prior exposure to idelalisib
  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Idelalisib (GS-1101)-Associated Colitis - Molecular and Cellular Mechanisms Research Proposal

This research trial studies the mechanisms of idelalisib-associated diarrhea in patients with chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, or small lymphocytic lymphoma that has come back after a period of improvement. The cancer treatment drug idelalisib triggers diarrhea in some patients. Studying stool, blood, and tissue samples in the lab from patients who are given idelalisib may help doctors learn more about the side effects and may help to treat them in future patients.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Colonoscopy, Colposcopic Biopsy, Idelalisib, Laboratory Biomarker Analysis
Medical subject headings
Lymphoma, B-Cell, Signs and Symptoms, Digestive, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Undergo biospecimen collection

  • ColonoscopyProcedure or surgery

    Undergo colonoscopy

  • Colposcopic BiopsyProcedure or surgery

    Undergo colposcopic biopsy

  • IdelalisibDrug

    Also called CAL-101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

  • Physical ExaminationProcedure or surgery

    Also called Assessment, Physical, Physical Assessment, PHYSICAL EXAM

    Undergo physical examination

  • SigmoidoscopyProcedure or surgery

    Also called Proctosigmoidoscopy

    Undergo sigmoidoscopy

Study groups in NCT02928510
Study groupRoleWhat they receive
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.
Receives: Procedure: Biospecimen Collection; Procedure: Colonoscopy; Procedure: Colposcopic Biopsy; Drug: Idelalisib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Physical Examination; Procedure: Sigmoidoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cellular mechanisms of idelalisib-induced diarrhea/colitis assessed by a number of tests in order to provide variability in comparisons for the units of measure.

    Measured: Up to 11 years

  2. The Mechanism of Action (MOA) of idelalisib will be assessed with a number of tests in order to provide variability in comparisons for the units of measure.

    Measured: Up to 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2016 (estimated)
  2. Study start1 Feb 2016
  3. Primary completion5 Jun 2018
  4. Study completion5 Jun 2018

Why it stopped: withdrawn by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02928510
Sponsor's protocol ID
15-001217
Other IDs
NCI-2016-01002, 15-001217
Status last verified
May 2021
First submitted
12 Aug 2016
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Absence of Signs or Symptoms and B-Cell Non-Hodgkin Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: withdrawn by sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cellular mechanisms of idelalisib-induced diarrhea/colitis assessed by a number of tests in order to provide variability in comparisons for the units of measure. (time frame: Up to 11 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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