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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02993536
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Other: Biospecimen Collection

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment
• Anticipated Study Start Date: Nov 1, 2015
• Anticipated Primary Completion Date: Nov 1, 2017

Outcome Measures

Primary Outcome Measures

1. Number of somatic hypermutation [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02993536
• Other Study ID Numbers: UPCC 30415
• First Posted: Dec 15, 2016
• Last Update Posted: Apr 16, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Apr 16, 2019