Lymphoma, Small LymphocyticREALNCT04342117
Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
An observational study of Lymphoma, Small Lymphocytic and Lymphoma, run by SecuraBio at 11 sites in United States.
Trial summary
This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Lymphocytic, Lymphoma, Lymphoma, Non-Hodgkin
- What is being tested?
- duvelisib and PI3K inhibitor
- How many people
- 2 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Apr 2020to 31 Dec 2020
- How long will I take part?
- 1 Day
- 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: Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled
Who may be able to join
- Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy
- Patients previously treated with PI3K-inhibitors are eligible for this study if they:
- Are restarting treatment with PI3K-inhibitor at enrollment, or
- Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
- Patients newly treated with PI3K-inhibitors are eligible for this study if they:
- Are starting treatment with PI3K-inhibitors at enrollment, or
Show all 10Show fewer
- Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
- ≥18 years of age at time consent is provided to participate in this study
- For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records
- Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)
Who cannot join
- Not applicable
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
McFarland Clinic,PC
Ames, Iowa, 50010
St. Agnes Hospital
Baltimore, Maryland, 21229
Regional Cancer Care Associates LLC
Bethesda, Maryland, 20817
Goshen General Hospital
Goshen, Indiana, 46526
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, 39401
Capital Region Medical Center
Jefferson City, Missouri, 65101
Joliet Oncology-Hematology Associates, LTD
Joliet, Illinois, 60435
CARTI Cancer Center
Little Rock, Arkansas, 72205
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
NY Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
Oncology Hematology Associates
Springfield, Missouri, 65807
About this study
Official title: PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.
Read the detailed description
Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.
- Conditions
- Lymphoma, Small Lymphocytic, Lymphoma, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Follicular Lymphoma
- Being tested
- duvelisib, PI3K inhibitor
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duvelisibDrug
Also called Copiktra, VS-0145
25 mg BID, 15 mg BID
PI3K inhibitorDrug
FDA approved PI3K inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Patients who take duvelisib. Receives: Drug: duvelisib | |
| Other PI3K-inhibitors | Patients who take a PI3K-inhibitor other than duvelisib Receives: Drug: PI3K inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Observe the effectiveness of the PI3K-inhibitor administered
Measured: 2 years
Secondary outcomes (4)
Measurement of Quality of Life - EQ-5D
EQ-5D is a widely used health status instrument, which developed by the EuroQol Group in the 1980s. It provides a concise and generic measure to compare and value health status across disease areas. The 5-level EQ-5D-5L was introduced in 2009 to improve the sensitivity of the instrument and reduce the ceiling effect. The EQ-5D-5L consists of the descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and the EQ visual analogue scale (VAS). The patient is asked to indicate his/her health state by choosing one of the 5 levels for each dimension: no problem, slight problems, moderate problems, severe problems and extreme problems. Each dimension has a 1-digit number that expresses the level selected for that dimension. The digit for the 5 dimensions will be combined into a 5-digit number that describes a patient's health profile. Results of the EQ VAS will be presented to measure overall self-rated health status.
Measured: 2 years
Measurement of Quality of Life - FACT-lym
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-lym) is a PRO measure used to assess HRQoL in patients undergoing cancer therapy. The instrument includes 27 questions on the impacts of cancer therapy over the past 7 days in four domains plus 15 questions related to lymphoma patients: physical, social/family, emotional, and functional over the past 7 days. Each question is answered using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), where higher numbers indicate better health state. Scores of each domain will be calculated by adding scores for questions included in each domain, and a total score for the FACT-Lym will be obtained by adding each of the subscale scores, with higher score indicating better health state.
Measured: 2 years
Characterize patient characteristics initiating treatment with PI3K-inhibitors
Patient demographics, medical and disease history, prior therapies, and dosing regimen
Measured: 2 years
Measure Time to Next Treatment (TTNT)
The length of time from the date the patient initiates PI3K-inhibitor treatment to the date of initiating the next line of therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start23 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Strategy Change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Small LymphocyticStudies of the same condition, open and under way.
- 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
- 2 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342117
- Sponsor's protocol ID
- VS-0145-401
- Acronym
- REAL
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT04342117
- Acronym / sponsor ID
- REAL / VS-0145-401
- Conditions
- Lymphoma, Small Lymphocytic, Lymphoma, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Strategy Change
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Apr 2020 (actual)
- 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.
This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.
Detailed description
Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib | – | Drug: duvelisibPatients who take duvelisib. |
| Other PI3K-inhibitors | – | Drug: PI3K inhibitorPatients who take a PI3K-inhibitor other than duvelisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 200 patients with a clinical or pathological diagnosis of CLL/SLL or pathological diagnosis of FL, for whom the Investigator has decided PI3K-inhibitor treatment is the appropriate therapy will be enrolled
Key inclusion criteria (10 listed)
- Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy
- ≥18 years of age at time consent is provided to participate in this study
- For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records
- Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| duvelisibAlso: Copiktra, VS-014525 mg BID, 15 mg BID | Drug | Duvelisib |
| PI3K inhibitorFDA approved PI3K inhibitors | Drug | Other PI3K-inhibitors |
Primary outcome
Event-Free Survival (EFS)
Time frame: 2 years
Observe the effectiveness of the PI3K-inhibitor administered
4 secondary outcomes
Measurement of Quality of Life - EQ-5D
Time frame: 2 years
Measurement of Quality of Life - FACT-lym
Time frame: 2 years
Characterize patient characteristics initiating treatment with PI3K-inhibitors
Time frame: 2 years
Measure Time to Next Treatment (TTNT)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Strategy Change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Small Lymphocytic and Lymphoma, run by SecuraBio at 11 sites 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 1 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: stopped early, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 stopped early (reason given: Strategy Change). Results are not available in the source record.
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?
Event-Free Survival (EFS) (time frame: 2 years). 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 17 Mar 2021.