Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
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|ClinicalTrials.gov Identifier: NCT02677948|
Recruitment Status : Withdrawn (FDA has placed all trials involving Pacritinib on Full Clinical Hold)
First Posted : February 9, 2016
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Lymphoma, Small Lymphocytic||Drug: Pacritinib Drug: Ibrutinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II, Open Label, Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Pacritinib and Ibrutinib
Phase I: Patients will receive Pacritinib 100-200 mg twice daily along with Ibrutinib 420mg/day.
Phase II Lead-In: Pacritinib at MTD daily continuous x 2 months followed by Pacritinib at MTD twice daily along with Ibrutinib 420mg/day.
- Then maximum tolerated dose (MTD) of Pacritinib when given in combination with Ibrutinib [ Time Frame: 28 Days ]DLTs (Dose Limiting Toxicities) occurring during the 1st cycle (first 28 days) of treatment with the combination of pacritinib and ibrutinib will be used for dose-escalation decisions. MTD is defined as the largest dose at which no more than 25% of patients experience a DLT.
- The number of patients with a Complete Response (CR) [ Time Frame: 2 Years Post Treatment ]
Patients will be followed for response from the date of initial treatment until 2 years post treatment. CR is defined as:
Lymphadenopathy - None ˃1.5 cm Hepatomegaly - None Splenomegaly - None Blood Lymphocytes - ˂ 4000/μL Bone Marrow - Normocellular, 30% lymphocytes, no B-lymphoid nodules. Platelet Count - ˃ 100,000/μL Hemoglobin - ˃ 11.0 g/dL Neutrophils - ˃ 1,500/μL
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): NCT02677948
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Ryan Wilcox, M.D.||University of Michigan Rogel Cancer Center|