Venetoclax + Dexamethasone for AL Amyloidosis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Venetoclax for AL Amyloidosis?
Research shows that Venetoclax, when used for relapsed or refractory AL Amyloidosis, achieved a high response rate of 88% in patients, with many experiencing significant improvements. Additionally, Venetoclax has shown effectiveness in treating other blood-related conditions, like chronic lymphocytic leukemia, with response rates around 80%.12345
What makes the drug Venetoclax + Dexamethasone unique for treating AL Amyloidosis?
Venetoclax is unique because it targets a specific protein called BCL-2, which helps cancer cells survive, making it different from other treatments that may not target this protein. Dexamethasone is often used to reduce inflammation and can help enhance the effects of Venetoclax, offering a novel combination approach for AL Amyloidosis.678910
What is the purpose of this trial?
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
Research Team
Rajshekhar Chakraborty, MD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for adults over 18 with relapsed or refractory AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have had prior treatments including an anti-CD38 antibody and be able to follow the study plan. They can't join if they're on dialysis, have certain infections like HIV without effective treatment, severe heart failure, previous use of BCL-2 inhibitors, or other serious health issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of venetoclax in combination with dexamethasone
Phase 2: Randomized Treatment
Randomized open-label study comparing the MTD or RP2D of venetoclax in combination with dexamethasone versus investigator's choice
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Venetoclax
Venetoclax is already approved in United States, European Union for the following indications:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Acute myeloid leukemia (AML)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rajshekhar Chakraborty, MD
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD