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

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT02993536
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Primary Completion: 2017-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of somatic hypermutation	12 months

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States