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

NCT ID: NCT02993536

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Brief Summary

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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

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biospecimen Collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Mato, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 30415

Identifier Type: -

Identifier Source: org_study_id

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