Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02160015|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2014
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ann Arbor Stage III Small Lymphocytic Lymphoma Ann Arbor Stage IV Small Lymphocytic Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Small Lymphocytic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Drug: Lenalidomide Biological: Rituximab||Phase 1|
I. To determine the recommended phase II doses of lenalidomide and ibrutinib for combination with rituximab in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma.
I. To determine the safety and tolerability of the combination of lenalidomide, ibrutinib and rituximab in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma.
II. To describe any preliminary evidence of antitumor activity of the combination of lenalidomide, rituximab and ibrutinib in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma as defined by response rate, duration of response, and progression-free survival.
III. To observe and record anti-tumor activity.
OUTLINE: This is a dose-escalation study of lenalidomide.
Patients receive rituximab intravenously (IV) on day 1 (up to 6 courses), lenalidomide orally (PO) once daily (QD) on days 1-21 (up to 12 courses), and ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and every 6 months for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Lenalidomide and Ibrutinib in Combination With Rituximab in Relapsed and Refractory CLL and SLL|
|Actual Study Start Date :||May 9, 2014|
|Actual Primary Completion Date :||March 27, 2017|
Experimental: Treatment (lenalidomide, ibrutinib, rituximab)
Patients receive rituximab IV on day 1 (up to 6 courses), lenalidomide PO QD on days 1-21 (up to 12 courses), and ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Recommended phase II dose of lenalidomide and ibrutinib with rituximab based on the maximum tolerated dose and the assessment of any clinically relevant toxicity graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 28 days ]
- Incidence of adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days following the last dose of ibrutinib ]Descriptive statistics will be used in the analysis of all laboratory and safety parameters (adverse events, serious adverse events, adverse events leading to discontinuation, deaths) for all treated patients.
- Overall response rate [ Time Frame: From the start of the treatment until disease progression/recurrence or death, assessed up to 10 years ]The proportion of patients who achieve stable disease (SD) or a partial response (PR) or complete response (CR) will be reported with a 95% exact binomial confidence interval.
- Complete response rates [ Time Frame: Up to 10 years ]The proportion of patients who achieve CR will be reported with a 95% exact binomial confidence interval.
- Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed up to 10 years ]
- Progression-free survival [ Time Frame: Time from start of treatment to time of progression or relapse or death, whichever occurs first, assessed up to 10 years ]The progression-free survival will be evaluated using the methods of Kaplan and Meier.
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): NCT02160015
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Bruce D Cheson||MedStar Georgetown University Hospital|