Safe Accelerated Venetoclax Escalation in CLL (SAVE)
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ClinicalTrials.gov Identifier: NCT04843904 |
Recruitment Status :
Recruiting
First Posted : April 14, 2021
Last Update Posted : December 12, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | March 30, 2021 | ||||||||||||||
First Posted Date ICMJE | April 14, 2021 | ||||||||||||||
Last Update Posted Date | December 12, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | April 14, 2021 | ||||||||||||||
Estimated Primary Completion Date | June 2, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Highest risk TLS group that can safely tolerate the daily ramp up [ Time Frame: 3 months ] Rates of laboratory and clinical TLS
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Safe Accelerated Venetoclax Escalation in CLL | ||||||||||||||
Official Title ICMJE | SAVE (Safe Accelerated Venetoclax Escalation): A Phase Ib Study of Venetoclax Monotherapy With Accelerated Dose Ramp-up in Patients With CLL | ||||||||||||||
Brief Summary | This research study is trying to determine which patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely tolerate an accelerated, daily venetoclax dose ramp-up rather than the standard approved schedule (5-week dose ramp-up). The name of the study drug involved in this study is:
The following drugs may also be included in some participants treatment regimen:
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Detailed Description | This is an open label phase Ib study of an accelerated venetoclax ramp-up in patients with CLL/SLL in either the front-line or relapsed/refractory setting. This clinical trial is testing a new dosing schedule of a drug that is normally dosed in a different fashion. As such, venetoclax is considered an investigational drug when given in this new schedule. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved venetoclax as a treatment option for CLL or SLL but the approval is based on a different schedule. Venetoclax is an oral drug inhibitor of BCL-2, a protein that regulates the death of cells in the body. It has been FDA approved with or without rituximab for the treatment of adult patients with CLL/SLL who have received at least one prior therapy, with obinutuzumab for frontline therapy of CLL/SLL, as well in combination with azacitabine, decitabine, or low-dose cytarabine for the treatment of adults with newly diagnosed acute myeloid leukemia (AML). Venetoclax is typically started at a low dose and increased on a weekly basis, over 5 weeks, to the desired dose for patients with CLL/SLL.This study is trying to determine if patients can safely increase the venetoclax dose in the hospital on a daily basis, over 5 days rather than weekly, and which patients, grouped by their risk for TLS, with newly diagnosed or relapsed/refractory CLL/SLL, are able to safely tolerate this accelerated, daily venetoclax dose ramp-up. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. All participants will be actively followed for approximately 3 months. Following completion of the active study period, participants will be encouraged to return for a response evaluation. Following this, patients will enter a long-term follow up period where they will be observed for a maximum of 5 years. It is expected that about 40 people will take part in this research study. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Venetoclax
Participants will be separated into two cohorts: Cohort A: Patients at low risk for TLS. Cohort B: Patients with both median and high risk for TLS. Five (5) participants from cohort A will be initially enrolled, if these first 5 participants tolerate the accelerated ramp-up, cohorts A and B will enroll simultaneously. All participants will be hospitalized and receive venetoclax daily with accelerated dose increases over 5 days to reach full dose. After reaching full dose, participants will be discharged and continue daily venetoclax at home. Per doctor assessment, some participants may also receive rituximab or obinutuzumab as part of the treatment regimen with venetoclax. Rituximab: Given every 28 days starting on the second study cycle and continuing for up to 6 cycles as per standard of care. Obinutuzumab: Days 1, 2, 8, and 15 of cycle 1 and once every 28 days there after for up to 6 cycles as per standard of care. Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
40 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | June 2, 2030 | ||||||||||||||
Estimated Primary Completion Date | June 2, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04843904 | ||||||||||||||
Other Study ID Numbers ICMJE | 20-415 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Jennifer Crombie, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Jennifer Crombie, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | December 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |