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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| AstraZeneca | INDUSTRY |
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The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bruton's tyrosine kinase inhibitor treatment | Patients treated with a Bruton's tyrosine kinase inhibitor. |
| |
| B-Cell Lymphoma 2 Protein Inhibitor treatment | Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bruton's tyrosine kinase inhibitor | Drug | BTKi |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQOL) | Compare the differences in HRQOL scores measured by the Functional Assessment of Cancer Therapy Leukemia version for patients receiving BTKi, and BCL2i within 7 days of beginning treatment and at days 30,60, 90, 180, 1 year, 1.5 years, and 2 years following initiation of treatment. | Up to 2 years |
| HRQOL predictors | Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models. | Up to 2 years |
| Interactions with treatment | Three models will assess interactions between treatment and age, comorbidity, and fatigue. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 18 years of age and older with a diagnosis of CLL/SLL who are starting treatment with either a Bruton tyrosine kinase inhibitor +/-an anti-CD 20 monoclonal antibody or a B cell lymphoma 2 inhibitor (BCL2i) with Obinutuzumab.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Lastorino | Contact | 813-745-0092 | Daniel.Lastorino@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Sara Tinsley-Vance, PhD, APRN, AOCN | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| B-Cell Lymphoma 2 Protein Inhibitor |
| Drug |
BCL2i |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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