Chronic Lymphocytic LeukemiaNCT02993536
Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab
An observational study of Chronic Lymphocytic Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Biospecimen Collection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with relapsed or refractory CLL requiring treatment and receiving idelalisib-rituximab
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment
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
- Being tested
- Biospecimen Collection
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of somatic hypermutation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startNov 2015 (estimated)
- Primary completionNov 2017 (estimated)
Why it stopped: Low likelihood to usedrug in clinic practice based on emergining AE profile and data from front line clinical trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Mato, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993536
- Sponsor's protocol ID
- UPCC 30415
- Status last verified
- Apr 2019
- First submitted
- 13 Dec 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment
- ClinicalTrials.gov ID
- NCT02993536
- Acronym / sponsor ID
- UPCC 30415
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low likelihood to usedrug in clinic practice based on emergining AE profile and data from front line clinical trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Nov 2015 (estimated)
- Primary completion
- Nov 2017 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with relapsed or refractory CLL requiring treatment and receiving idelalisib-rituximab
Key inclusion criteria (10 listed)
- Age over 18
- Ability to provide informed consent
- Ability to provide peripheral blood samples
- Diagnosis of CLL
- Indication(s) for CLL therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen Collection | Other | – |
Primary outcome
Number of somatic hypermutation
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mato, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of somatic hypermutation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.