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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02993536
• Other study ID #: UPCC 30415
• Status: Withdrawn
• Start date: November 2015

Study information

• Verified date: April 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Other:
• Biospecimen Collection

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of somatic hypermutation		12 months