Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 1:09 AM
Study NCT ID:
NCT04843904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Accelerated Venetoclax Escalation in CLL
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
SAVE (Safe Accelerated Venetoclax Escalation): A Phase Ib Study of Venetoclax Monotherapy With Accelerated Dose Ramp-up in Patients With CLL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
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:
* Venetoclax
The following drugs may also be included in some participants treatment regimen:
* Obinutuzumab
* Rituximab
The name of the study drug involved in this study is:
* Venetoclax
The following drugs may also be included in some participants treatment regimen:
* Obinutuzumab
* Rituximab
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: