AL Amyloidosis Clinical Trial
Official title:
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis
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.
This study is a phase 1/2 study of venetoclax-dexamethasone combination therapy in relapsed/refractory t(11;14) systemic immunoglobulin light chain amyloidosis (AL) amyloidosis. The phase 1 is a dose escalation designed to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of venetoclax in combination with low-dose weekly dexamethasone. There will be four candidate-dosing cohorts of venetoclax with or without dexamethasone in the Phase I dose-escalation. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design with accelerated titration up to a total sample size of 15 participants. The phase 2 portion is a randomized open-label study comparing the MTD or RP2D of venetoclax in combination with dexamethasone versus investigator's choice (daratumumab, pomalidomide, bendamustine, or ixazomib (with or without dexamethasone). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02574676 -
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
|
||
Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
Active, not recruiting |
NCT05199337 -
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
Completed |
NCT01409148 -
Radioimmunoimaging of AL Amyloidosis
|
Phase 1 | |
Active, not recruiting |
NCT04512235 -
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis
|
Phase 3 | |
Recruiting |
NCT06383143 -
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
|
||
Recruiting |
NCT05277493 -
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
|
||
Completed |
NCT02632786 -
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
|
Phase 2 | |
Completed |
NCT02841033 -
Daratumumab for the Treatment of Patients With AL Amyloidosis
|
Phase 1/Phase 2 | |
Completed |
NCT04304144 -
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
|
Phase 2 | |
Recruiting |
NCT01408225 -
Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
|
||
Recruiting |
NCT04895917 -
Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis
|
Phase 2 | |
Terminated |
NCT02489500 -
Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
|
Phase 3 | |
Completed |
NCT01570387 -
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
|
Phase 1/Phase 2 | |
Terminated |
NCT03154047 -
Study in Subjects With Light Chain (AL) Amyloidosis
|
Phase 2 | |
Completed |
NCT03236792 -
Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04392960 -
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
|
N/A | |
Recruiting |
NCT05898646 -
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
|
Phase 2 | |
Not yet recruiting |
NCT06022939 -
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
|
Phase 3 |