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

NCT02993536 | Withdrawn DMC

• 1 other identifier: UPCC 30415
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of somatic hypermutation

  12 months

Interventions

Biospecimen Collection OTHER

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony Mato, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)