Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02992522|
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3a Follicular Lymphoma Recurrent Burkitt Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent Follicular Lymphoma Recurrent Marginal Zone Lymphoma Refractory Burkitt Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Follicular Lymphoma Transformed Recurrent Non-Hodgkin Lymphoma||Drug: Lenalidomide Biological: Obinutuzumab Drug: Venetoclax||Phase 1|
I. To determine the dose limiting toxicity (DLT) and the recommended phase 2 dose (RP2D), which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
I. To estimate the overall objective response rate to the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell NHL.
II. To estimate the duration of response and 2 year progression-free survival associated with obinutuzumab, venetoclax, and lenalidomide treatment in patients with relapsed and refractory B-cell NHL.
III. To define the qualitative and quantitative toxicities of the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell NHL.
OUTLINE: This is a dose-escalation study of venetoclax and lenalidomide.
Patients receive lenalidomide orally (PO) on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of course 1 and on day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, then every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Obinutuzumab, Venetoclax, and Lenalidomide in Relapsed and Refractory B-cell Non-Hodgkin Lymphoma|
|Actual Study Start Date :||February 21, 2017|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Treatment (lenalidomide, venetoclax, obinutuzumab)
Patients receive lenalidomide PO on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1, and day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4 [ Time Frame: Up to 28 days ]The recommended phase 2 dose (RP2D), which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- Objective response rate (ORR) defined as the proportion of patients achieving a complete or partial, response according to the Lugano Lymphoma Response Criteria [ Time Frame: Up to 3 years ]ORR will be reported with a 95% binomial confidence interval.
- Progression-free survival [ Time Frame: From course 1 day 1 to the date of the event (i.e., death or disease progression), assessed up to 2 years ]PFS will be estimated using the method of Kaplan-Meier. Median PFS and 2-year PFS estimates will be reported with 95% confidence intervals. If applicable, a sensitivity analysis of PFS will include any eligible patient who receives at least one dose of study treatment (i.e. venetoclax alone without beginning the combination regimen).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992522
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Beth A. Christian, MD 614-293-7807 email@example.com|
|Contact: Pam Heeter 614-293-9627 firstname.lastname@example.org|
|Principal Investigator: Beth A. Christian, MD|
|Principal Investigator:||Beth Christian, MD||Ohio State University Comprehensive Cancer Center|