Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05451771 · ClinicalTrials.gov registry record · Phase 1
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
A Phase 1 study of AL Amyloidosis, sponsored by Rajshekhar Chakraborty, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 4
- Study locations
NCT05451771: Recruiting Phase 1 study of AL Amyloidosis, sponsored by Rajshekhar Chakraborty, MD.
NCT05451771 is a Phase 1 study of AL Amyloidosis that is actively recruiting participants, run by Rajshekhar Chakraborty, MD. The registered enrollment target is 53 participants, below the 421-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05451771, a Phase 1 study of AL Amyloidosis, is actively recruiting participants, sponsored by Rajshekhar Chakraborty, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
The number of participants with dose limiting toxicities for each treatment dose will be used to determine the MTD. Dose limiting toxicity defined as grade 4 neutropenia lasting more than 5 days, any grade febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with bleeding, other therapy related non-hematologic toxicity of grade 2 or higher that requires discontinuation of therapy, clinical tumor lysis syndrome (TLS), laboratory TLS if the metabolic abnormalities are considered
Conditions Studied
Interventions
- DRUG Venetoclax Oral Tablet, 200 mg
- DEVICE FISH assay
- DRUG Venetoclax Oral Tablet, 400 mg
- DRUG Dexamethasone Oral, 10 mg
- DRUG Dexamethasone Oral, 20 mg
Study Locations (4)
Massachusetts
- Boston Medical Center - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center - New York
Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What NCT05451771 shows while recruiting
NCT05451771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 421-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax Oral Tablet, 200 mg is the first listed.
NCT05451771 reports a single indexed study location in Massachusetts, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT05451771 about?
NCT05451771 is a clinical study titled "Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) 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.
What is the current status of trial NCT05451771?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2022-10-26. Estimated completion is 2026-09.
What conditions does trial NCT05451771 study?
This clinical trial studies the following conditions: AL Amyloidosis.
What interventions are being tested in trial NCT05451771?
The interventions under investigation include: Venetoclax Oral Tablet, 200 mg (DRUG), FISH assay (DEVICE), Venetoclax Oral Tablet, 400 mg (DRUG), Dexamethasone Oral, 10 mg (DRUG), Dexamethasone Oral, 20 mg (DRUG).
Who is sponsoring clinical trial NCT05451771?
This trial is sponsored by Rajshekhar Chakraborty, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05451771 being conducted?
This trial has 4 study locations across Massachusetts, Minnesota, New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05451771's enrollment target sits among peer trials
53 7th of 15 higher than 9 of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
RECRUITING · Phase 1
-
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
RECRUITING · Phase 1
-
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
ACTIVE NOT RECRUITING · Phase 1
-
Radioimmunoimaging of AL Amyloidosis
COMPLETED · Phase 1
-
Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
RECRUITING
-
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04177004 · 53 participants · Phase 1
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
- NCT04199741 · 53 participants · Phase 1
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
- NCT04835129 · 53 participants · Phase 2
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
- NCT04913805 · 53 participants · Phase 2
Matching Perfusion and Metabolic Activity in HFpEF
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI