NCT02928510

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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

• 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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo biospecimen collection
PROCEDURE	Colonoscopy	Undergo colonoscopy
PROCEDURE	Colposcopic Biopsy	Undergo colposcopic biopsy
DRUG	Idelalisib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
PROCEDURE	Physical Examination	Undergo physical examination
PROCEDURE	Sigmoidoscopy	Undergo sigmoidoscopy

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-06-05
• Completion: 2018-06-05
• First posted: 2016-10-10
• Last updated: 2021-07-14

Locations

1 site across 1 country: United States