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

NCT02928510 | Terminated

• 2 other identifiers: 15-001217NCI-2016-01002
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Absence of Signs or Symptoms; B-Cell Non-Hodgkin Lymphoma; Digestive System Signs and Symptoms; Indolent Adult Non-Hodgkin Lymphoma; Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Indolent Adult Non-Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 11 years

• 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.

  Up to 11 years

Study Arms (1)

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.

Procedure: Biospecimen Collection; Procedure: Colonoscopy; Procedure: Colposcopic Biopsy; Drug: Idelalisib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Physical Examination; Procedure: Sigmoidoscopy

Interventions

Biospecimen Collection PROCEDURE

Undergo biospecimen collection

Basic Science (biospecimen collection, idelalisib)

Colonoscopy PROCEDURE

Undergo colonoscopy

Basic Science (biospecimen collection, idelalisib)

Colposcopic Biopsy PROCEDURE

Undergo colposcopic biopsy

Basic Science (biospecimen collection, idelalisib)

Idelalisib DRUG

Given PO

Also known as: CAL-101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig

Basic Science (biospecimen collection, idelalisib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Basic Science (biospecimen collection, idelalisib)

Pharmacological Study OTHER

Correlative studies

Basic Science (biospecimen collection, idelalisib)

Physical Examination PROCEDURE

Undergo physical examination

Also known as: Assessment, Physical, Physical Assessment, PHYSICAL EXAM

Basic Science (biospecimen collection, idelalisib)

Sigmoidoscopy PROCEDURE

Undergo sigmoidoscopy

Also known as: Proctosigmoidoscopy

Basic Science (biospecimen collection, idelalisib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool and biopsies from sigmoidoscopy

MeSH Terms

Conditions

Lymphoma, B-Cell; Signs and Symptoms, Digestive; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Colonoscopy; idelalisib; Restraint, Physical; Sigmoidoscopy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Daniel Hommes

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: October 10, 2016
• Study Start: February 1, 2016
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: July 14, 2021

Record last verified: 2021-05

Locations

US (1)