Venetoclax and Selinexor in Treating Patients With Relapsed or Refractory High Risk Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03955783|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma Acute Myeloid Leukemia Non-Hodgkin's Lymphoma||Drug: Venetoclax Drug: Selinexor||Phase 1|
- Escalation: Identify the maximum tolerated dose(s) (MTD) and recommended phase 2 dose(s) (RP2D) of SEL-VEN combination therapy in patients with diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukemia (AML).
- Expansion: Determine the overall response rate of SEL-VEN combination therapy in patients with relapsed/refractory hematologic malignancies.
- To explore biomarkers of response to SEL-VEN therapy.
- To determine the progression free survival (PFS) and overall survival (OS) of SEL-VEN combination therapy.
OUTLINE: This is a dose-escalation study.
Patients receive venetoclax orally (PO) once daily (QD) on days 1-28. Patients with DLBCL receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Patients with venetoclax-naive AML are treated with selinexor on days 8, 15, and 22 of cycle 1, followed by days 1, 8, 15, and 22 of subsequent cycles. Venetoclax-refractory AML patients begin both drugs on cycle 1 day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days and every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator-Sponsored Phase Ib Trial of Venetoclax and SINE: Selective Inhibition of Nuclear Export in Patients With High Risk Hematologic Malignancies|
|Actual Study Start Date :||June 21, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2023|
Experimental: Treatment (venetoclax, selinexor)
Patients receive venetoclax PO QD on days 1-28. Patients with DLBCL receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Venetoclax naïve AML patients receive selinexor on days 8, 15, and 22 of cycle 1, followed by days 1, 8, 15, and 22 of subsequent cycles. Venetoclax refractory AML patients receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given by mouth
Given by mouth
- Maximum tolerated dose (escalation) [ Time Frame: Up to 28 days ]
- Overall response rate (expansion) [ Time Frame: At 12 weeks ]
- Progression free survival [ Time Frame: Up to 2 years ]Will be estimated using the Kaplan-Meier method with 95% confidence intervals. Descriptive statistics will be used to summarize survival outcomes among subgroups. Will be compared with historical controls of patients that received venetoclax monotherapy
- Overall survival [ Time Frame: Up to 2 years ]Will be estimated using the Kaplan-Meier method with 95% confidence intervals. Descriptive statistics will be used to summarize survival outcomes among subgroups. Will be compared with historical controls of patients that received venetoclax monotherapy.
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): NCT03955783
|Contact: Vanderbilt-Ingram Service Information Programemail@example.com|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Vanderbilt-Ingram Service Information Program 800-811-8480 firstname.lastname@example.org|
|Principal Investigator: Michael Byrne, DO|
|Principal Investigator:||Michael Byrne, DO||Vanderbilt Medical Center|