Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT02240719|
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Refractory Chronic Lymphocytic Leukemia Multiple Myeloma||Drug: everolimus Drug: bendamustine hydrochloride||Phase 1|
I. To determine the maximum tolerated dose (MTD) of everolimus when administered in combination with bendamustine (bendamustine hydrochloride) in defined hematologic malignancies.
II. To determine the safety and tolerability of administering everolimus in combination with bendamustine chemotherapy.
I. To determine the efficacy of everolimus when administered in combination with bendamustine in adult patients with relapsed/refractory hematological malignancies.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2 and everolimus orally (PO) once daily (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 for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Everolimus + Bendamustine in Patients With Relapsed/Refractory Hematological Malignancies|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 9, 2018|
|Actual Study Completion Date :||April 9, 2018|
Experimental: Everolimus + Bendamustine
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2 and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: bendamustine hydrochloride
- MTD of everolimus, defined as the dose that produces dose-limiting toxicity (DLT) in =< 1/6 patients, determined by incidence of DLT graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 28 days ]The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI CTCAE version 4.0) and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
- Incidence and severity of adverse events as defined by the NCI CTCAE version 4.03 [ Time Frame: Up to 30 days post-treatment ]
- Response rates (complete response, partial response, stable disease) [ Time Frame: Up to 30 days post-treatment ]Response rate among patients with measurable disease will be summarized by exact binomial confidence intervals.
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): NCT02240719
|United States, California|
|University of California Davis|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mehrdad Abedi||University of California, Davis|