informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/21/2019 |
Start Date: | September 2015 |
End Date: | October 2021 |
Contact: | 1134 Study Team |
Email: | medinfo@pcyc.com |
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).
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).
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.
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.
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)
We found this trial at
204
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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131 Lila Doyle Drive
Seneca, South Carolina 29672
Seneca, South Carolina 29672
(864) 888-3717
Cancer Centers of the Carolinas - Seneca Cancer Centers of the Carolinas is now Cancer...
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120 Dillon Dr
Spartanburg, South Carolina 29307
Spartanburg, South Carolina 29307
(864) 699-5700
Cancer Centers of the Carolinas - Spartanburg Cancer Centers of the Carolinas is now Cancer...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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835 South Van Buren Street
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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