Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT03041636|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Untreated Chronic Lymphocytic Leukemia||Drug: Ruxolitinib Drug: Ruxolitinib Phosphate||Phase 2|
I. To determine the effect of ruxolitinib phosphate (ruxolitinib) in patients with high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who do not require anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations and were either previously untreated or treated with Ibrutinib for less than 3 months and were deemed Ibrutinib intolerant:
Ia. On disease burden. Ib. The rate of complete response (CR) and partial response (PR) as assessed by the IWCLL 2008 response criteria.
I. To evaluate the time to next treatment of high-risk CLL/SLL who do not require anti-neoplastic therapy according to the IWCLL 2008 recommendations.
Patients receive ruxolitinib phosphate orally (PO) twice daily (BID). Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of Jakafi (Ruxolitinib) to Patients With Previously Untreated High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): A Phase II Clinical Trial|
|Actual Study Start Date :||March 8, 2017|
|Estimated Primary Completion Date :||March 8, 2021|
|Estimated Study Completion Date :||March 8, 2021|
Experimental: Treatment (ruxolitinib phosphate)
Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.
Drug: Ruxolitinib Phosphate
- Clinical response [ Time Frame: Up to 6 months after initiation of therapy ]Defined as complete response, partial response, and a 20% reduction in tumor mass as assessed by computed tomography scan and bone marrow aspiration/biopsy. Assessed by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 response criteria.
- Change of tumor burden [ Time Frame: Baseline up to 6 months after initiation of therapy ]The paired t test will be used. Longitudinal analysis may be used to model the change in tumor burden.
- Response rate [ Time Frame: Up to 30 days ]Will be estimated with 95% confidence interval.
- Time to next treatment [ Time Frame: Up to 30 days ]Evaluated according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations. Will be estimated using the Kaplan-Meier method and will compare to historical data using Cox proportional hazards model, adjusting for effects of covariates.
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): NCT03041636
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Zeev Estrov||M.D. Anderson Cancer Center|