AL Amyloidosis Clinical Trial
Official title:
A Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis
This is a study to determine the safety, tolerability and maximum tolerated dose of Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL) amyloidosis patients.
The study is being conducted to determine the safety, tolerability and maximum tolerated dose
of Venetoclax and dexamethasone in relapsed or refractory amyloid light chain (AL)
amyloidosis patients. AL amyloidosis is a disease involving cells called plasma cells that
make antibodies as part of your immune system. These cells are not functioning the way they
are supposed to and they start to produce abnormal fragments of antibodies that are toxic to
your body and can form amyloid. The antibody fragments are called "light chains." They can
cause damage to organs, especially the kidneys, heart, skin, liver, and lungs.
Researchers are looking for ways to stop the light chains from being formed to treat the
disease. Under some circumstances, patients will receive chemotherapy drugs in order to
manage the disease. However, researchers do not know what the best treatment is for relapsed
AL amyloidosis, so the researchers are testing new drugs or new combinations of drugs to see
what will work best with the least side effects.
The researchers want to find out if Venetoclax (ABT-199) in addition to dexamethasone will
reduce or eliminate AL amyloidosis plasma cells. In this study, varying doses of Venetoclax
will be given to determine the maximum tolerated and safe dose for further study. The
researchers may also gain a better understanding of whether Venetoclax and dexamethasone can
counter the plasma cell disease that causes AL amyloidosis.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02574676 -
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
|
||
| Recruiting |
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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 |
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Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Completed |
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Radioimmunoimaging of AL Amyloidosis
|
Phase 1 | |
| Active, not recruiting |
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A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis
|
Phase 3 | |
| Recruiting |
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Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
|
||
| Recruiting |
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A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
|
||
| Completed |
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|
Phase 2 | |
| Completed |
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Daratumumab for the Treatment of Patients With AL Amyloidosis
|
Phase 1/Phase 2 | |
| Completed |
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A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
|
Phase 2 | |
| Recruiting |
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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 |
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Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
|
Phase 3 | |
| Completed |
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A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
|
Phase 1/Phase 2 | |
| Terminated |
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Study in Subjects With Light Chain (AL) Amyloidosis
|
Phase 2 | |
| Completed |
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Phase 1/Phase 2 | |
| Recruiting |
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Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
|
N/A | |
| Recruiting |
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Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
|
Phase 2 |