Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT03359460|
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome Previously Treated Myelodysplastic Syndrome Refractory High Risk Myelodysplastic Syndrome Secondary Myelodysplastic Syndrome Therapy-Related Myelodysplastic Syndrome||Drug: Ibrutinib Drug: Lenalidomide||Phase 1|
To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS).
To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS.
To examine the pharmacodynamic and biological effects of the combination of ibrutinib and lenalidomide in MDS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of the Combination of Ibrutinib and Lenalidomide for the Treatment of Patients With MDS Who Have Failed or Refuse Standard Therapy|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: Treatment (lenalidomide, ibrutinib)
Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
- Maximum tolerated dose [ Time Frame: Up to 28 days ]Data will be reported in tables with descriptive statistics used. Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Effects (CTCAE) version 4.03. Tables will be created to summarize the toxicities and adverse effects by dose, course, organ and severity as well as the study demographics.
- Disease free survival [ Time Frame: From the time of first documented complete response until relapse or the date of death from any cause, assessed up to 6 months ]Will be summarized with Kaplan-Meier plots.
- Disease response [ Time Frame: Up to 6 months ]Will be assessed per modified International Working Group (IWG) 2006 response criteria. Response rates and the corresponding 95% confidence intervals will be obtained.
- Hematologic normalization rate [ Time Frame: Up to 6 months ]Will be assessed as complete remission + partial remission + hematologic improvement.
- Overall survival [ Time Frame: From the time of first study drug administration until the date of death from any cause, assessed up to 6 months ]Will be summarized with Kaplan-Meier plots.
- Progression free survival [ Time Frame: From the time of first study drug administration until the date of progression or death from any cause, assessed up to 6 months ]Will be summarized with Kaplan-Meier plots.
- Time to response [ Time Frame: From the time of first study drug administration to the date of complete remission, partial remission, or hematologic improvement, assessed up to 6 months ]Will be summarized with Kaplan-Meier plots.
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): NCT03359460
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Brian A. Jonas 916-734-3772 email@example.com|
|Principal Investigator: Brian A. Jonas|
|Principal Investigator:||Brian Jonas||University of California, Davis|