Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age (PrE0405)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03834688|
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : November 19, 2020
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion.
Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die.
The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Venetoclax Drug: Bendamustine Drug: Rituximab||Phase 2|
Mantle cell lymphoma (MCL) is a subtype of Non-Hodgkin Lymphoma (NHL) which is considered incurable with conventional therapy. With an incidence of approximately 70,000 cases diagnosed in the United States (US) per year, the disease is rare.
This is an open-label phase II study of venetoclax in combination with bendamustine and rituximab. Patients will receive induction therapy with venetoclax, bendamustine and rituximab for six cycles (1 cycle = 28 days). There will be an interim analysis after 19 patients are enrolled to evaluate for tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells which can lead to electrolyte and kidney problems.
Tumor assessments will be performed after Cycle 3-4 and at end of induction therapy.
Mandatory pre-treatment tumor tissue sample (i.e., obtained in the course of standard biopsy or surgery) will be required for research (if sufficient tissue is available).
Mandatory bone marrow aspirate (obtained in the course of standard biopsy) and peripheral blood sample will be collected at the end of treatment for Minimal Residual Disease (MRD). MRD measures the disease remaining after treatment. Optional peripheral blood samples will also be collected for future research.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-Label, Single-Arm Study, Cycle 1 Dose Escalation|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2025|
Venetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days.
Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.)
Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days).
Cycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions.
Other Name: Bendamustine hydrochloride
Cycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously.
- Complete Response (CR) rate at end of induction [ Time Frame: 30 months ]CR assessed in accordance with Lymphoma Response Criteria (Cheson Criteria)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 60 months ]Number of participants with abnormal laboratory values and/or adverse events with particular attention to TLS related to treatment
- Overall Response Rate (ORR) [ Time Frame: 60 months ]ORR assessed in accordance with Lymphoma Response Criteria (Cheson Criteria)
- Progression-Free Survival (PFS) [ Time Frame: 60 months ]PFS assessed in accordance with Lymphoma Response Criteria (Cheson Criteria)
- Overall Survival (OS) [ Time Frame: 60 months ]OS assessed in accordance with Lymphoma Response Criteria (Cheson Criteria)
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): NCT03834688
|Contact: Carolyn Andrews, RN||267-207-4070||PrE0405@precogllc.org|
|United States, Illinois|
|Carle Cancer Center||Recruiting|
|Urbana, Illinois, United States, 61801|
|Contact: Pauline Mbuvi 217-383-4085 firstname.lastname@example.org|
|Principal Investigator: Priyank Patel, MD|
|United States, Indiana|
|Indiana University Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jill Weisenbach 317-278-0597 email@example.com|
|Principal Investigator: Michael Robertson, MD|
|United States, Kansas|
|University of Kansas||Recruiting|
|Overland Park, Kansas, United States, 66210|
|Contact: Sherri Miller 913-574-0266 firstname.lastname@example.org|
|Principal Investigator: Marc Hoffman, MD|
|United States, Michigan|
|St. Joseph Mercy Hospital Cancer Care Center||Recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Contact: Kellie Miller 734-712-6651 email@example.com|
|Principal Investigator: Christopher M. Reynolds, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Katie Elert 507-538-3227 firstname.lastname@example.org|
|Principal Investigator: Nabila (Nora) Bennani, MD|
|United States, Missouri|
|Washington University School of Medicine Siteman Cancer Center||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Chapelle Ayres 314-388-6506 email@example.com|
|Principal Investigator: Brad Kahl, MD|
|United States, Pennsylvania|
|Penn State Cancer Institute||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Kathleen Rizzo 717-531-0003 ext 289630 firstname.lastname@example.org|
|Principal Investigator: Seema Naik, MD|
|Reading Hospital/McGlinn Cancer Institute||Recruiting|
|West Reading, Pennsylvania, United States, 19611|
|Contact: Barbara Miller 484-628-8549 email@example.com|
|Principal Investigator: Terrence Cescon, MD|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22903|
|Contact: Erica Stallard 434-243-2649 firstname.lastname@example.org|
|Principal Investigator: Craig Portell, MD|
|United States, Wisconsin|
|Gundersen Health System||Recruiting|
|La Crosse, Wisconsin, United States, 54601|
|Contact: Kaitlin Chambers 608-775-1826 email@example.com|
|Principal Investigator: Kurt Oetell, MD|
|Study Chair:||Craig Portell, MD||University of Virginia|