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

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ClinicalTrials.gov Identifier: NCT02993536
Recruitment Status : Withdrawn (Low likelihood to usedrug in clinic practice based on emergining AE profile and data from front line clinical trials)
First Posted : December 15, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
Chronic Lymphocytic Leukemia Other: Biospecimen Collection

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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
Estimated Study Start Date : November 2015
Estimated Primary Completion Date : November 2017





Primary Outcome Measures :
  1. Number of somatic hypermutation [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with relapsed or refractory CLL requiring treatment and receiving idelalisib-rituximab
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993536


Locations
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United States, Pennsylvania
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
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Principal Investigator: Anthony Mato, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02993536     History of Changes
Other Study ID Numbers: UPCC 30415
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Idelalisib
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action