Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab

April 12, 2019 updated by: Abramson Cancer Center of the University of Pennsylvania

Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment

The purpose of the study is to assess the evolution of B cells at a genetic and surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per FDA label. This is an observational study for peripheral blood samples of these patients collected at pre-determined time points.

Study Overview

Status

Withdrawn

Conditions

Chronic Lymphocytic Leukemia

Intervention / Treatment

Other: Biospecimen Collection

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with relapsed or refractory CLL requiring treatment and receiving idelalisib-rituximab

Description

Inclusion Criteria:

Age over 18
Ability to provide informed consent
Ability to provide peripheral blood samples
Diagnosis of CLL
Indication(s) for CLL therapy
At least one criterion for high-risk disease
- Disease refractory (e.g., no response) to at least one round of chemotherapy
- Disease that has relapsed (i.e., returned) after at least one round of chemotherapy
- Proven presence of the 17p deletion within CLL cells
Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's oncologists

Exclusion Criteria:

Patients who do not meet the diagnostic criteria for CLL or at least one indication for treatment.
Patients who are receiving idelalisib with an off-label indication
Patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility
Patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of somatic hypermutation Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Anthony Mato, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria