informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia (informCLL)
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| ClinicalTrials.gov Identifier: NCT02582879 |
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Recruitment Status :
Recruiting
First Posted : October 21, 2015
Last Update Posted : December 24, 2018
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Sponsor:
Pharmacyclics LLC.
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Pharmacyclics LLC.
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Brief Summary:
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
| Condition or disease |
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| Chronic Lymphocytic Leukemia (CLL) |
InformCLL is a multicenter, prospective, observational registry of CLL patients designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL/SLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia |
| Study Start Date : | September 2015 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | October 2021 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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Patient with CLL/SLL
Patients with CLL/SLL in a real-world setting initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens.
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Primary Outcome Measures :
- Summarize baseline characteristics of study population, among CLL patients in a real-world setting [ Time Frame: up to 6 years ]- Summarize baseline characteristics of study participants
- Summarize treatment patterns among CLL patients in a real-world setting [ Time Frame: up to 6 years ]
- Summarize number of participants on various initial and subsequent treatments
- Summarize proportion of patients switching therapies at each follow up time point
- Summarize clinical outcomes among CLL patients in a real-world setting [ Time Frame: up to 6 years ]- Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease
- Summarize health care resource utilization among CLL patients in a real-world setting [ Time Frame: up to 6 years ]- Summarize health care resource utilization among study participants
Secondary Outcome Measures :
- Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients [ Time Frame: up to 6 years ]- Summarize frequencies and percentages of AEs, that led to discontinuation/modification/interruption of therapy or death in CLL patients
- Summarize patient-reported HRQoL scores [ Time Frame: up to 6 years ]- Summarize HRQoL scores as measured by FACT-G and additional questions from other PRO instruments at baseline and each follow-up
Biospecimen Retention: Samples With DNA
blood samples
Information from the National Library of Medicine
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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: | Non-Probability Sample |
Study Population
Patients with CLL/SLL from approximately 200 sites in the US over a 36-month enrollment period. Approximately 1000 patients will be initiating novel therapies including oral kinase inhibitors and approximately 500 patients initiating other approved anti-CLL therapies/regimens for the treatment of CLL/SLL. Approximately 85% of sites will include sites from the community hematology-oncology setting.
Criteria
Inclusion Criteria:
- Age of at least 18 years
- Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
- Initiating treatment within ±45 days of enrollment with novel therapies including oral kinase inhibitors (e.g., inhibitors of BTK [e.g., ibrutinib],inhibitors of BCL-2 pathway [ e.g venetoclax] or PI3K [e.g., idelalisib]), or with other anti-CLL therapies/regimens approved at the time of patient enrollment
- Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records
- Willing and able to provide informed consent
- Willing and able to complete PRO instrument
- Willing and able to provide information on patient survey questionnaire
- Willing and able to provide a blood sample at time of enrollment
Exclusion Criteria:
- Diagnosis of B-cell malignancies other than CLL/SLL
- Estimated life expectancy <6 months
- Currently receiving treatment in an interventional clinical trial with a non-approved, investigational agent for CLL/SLL at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)
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): NCT02582879
Contacts
| Contact: 1134 Study Team | medinfo@pcyc.com |
Show 204 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen, LP
Publications:
| Responsible Party: | Pharmacyclics LLC. |
| ClinicalTrials.gov Identifier: | NCT02582879 History of Changes |
| Other Study ID Numbers: |
PCYC-1134M-CA |
| First Posted: | October 21, 2015 Key Record Dates |
| Last Update Posted: | December 24, 2018 |
| Last Verified: | December 2018 |
Keywords provided by Pharmacyclics LLC.:
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Chronic Lymphocytic Leukemia CLL Small Lymphocytic Leukemia SLL |
Additional relevant MeSH terms:
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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 |