Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02131584|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Fatigue||Other: Questionnaire Administration Drug: Ruxolitinib Phosphate||Phase 2|
I. To estimate the reduction in fatigue as measured by the Brief Fatigue Inventory (BFI) of patients with chronic lymphocytic leukemia (CLL) who do not require anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations.
I. To estimate the reduction in other symptoms using the M. D. Anderson Symptom Inventory (MDASI) and to assess disease burden and response by the IWCLL 2008 response criteria.
Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study|
|Actual Study Start Date :||September 2, 2014|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Supportive care (ruxolitinib phosphate)
Patients receive ruxolitinib phosphate PO BID (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
Drug: Ruxolitinib Phosphate
- Change in fatigue as measured by the Brief Fatigue Inventory (BFI) question 3 regarding the worst fatigue in the past 24 hours [ Time Frame: Baseline to 3 months ]Will be analyzed in a continuous fashion.
- Proportion of patients with 2 point reductions in the BFI #3 score [ Time Frame: Up to 3 months ]Proportion of patients at 3 months versus at enrollment tabulated.
- 20% improvement in symptoms as measured by the M. D. Anderson Symptom Inventory (MDASI) [ Time Frame: Up to 3 months ]
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): NCT02131584
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Zeev Estrov||M.D. Anderson Cancer Center|