An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years at time of signing Informed Consent Form

• Ability to comply with the study protocol, in the investigator's judgment

• Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy

• Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody

• Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities

• Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Locations
United States
Massachusetts
Boston Medical Center
RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
New York
New York Presbyterian Hospital/Columbia University Irving Medical Center
RECRUITING
New York
Wisconsin
Froedtert Hospital & the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2026-09
Participants
Target number of participants: 53
Treatments
Experimental: Phase 1: Venetoclax 200 mg
Cohort 1: Venetoclax 200 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Experimental: Phase 1: Venetoclax 400mg
Cohort 2: Venetoclax 400 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Experimental: Phase 1: Venetoclax 400mg + Dexamethasone 10 mg
Cohort 3: Venetoclax 400 mg tablet, once daily and Dexamethasone 10 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Experimental: Phase 1: Venetoclax 400mg + Dexamethasone 20 mg
Cohort 4: Venetoclax 400 mg tablet, once daily and Dexamethasone 20 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Experimental: Phase 2: Venetoclax MTD with Dexamethasone
Venetoclax MTD (200 mg or 400 mg) with Dexamethasone (10 mg or 20 mg) as determined by the phase I results
Active_comparator: Phase 2: Control Arm (Investigator's Choice)
Participants will receive one of the following as determined by the investigator:~Daratumumab, Pomalidomide, Bendamustine, or Ixazomib (+/- dexamethasone)
Related Therapeutic Areas
Primary Amyloidosis
Sponsors
Collaborators: Genentech, Inc.
Leads: Rajshekhar Chakraborty, MD

This content was sourced from clinicaltrials.gov

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