AL Amyloidosis Clinical Trial

Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

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.

View Full Description

Full Description

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Known hypersensitivity to any of the study drugs
History of other malignancy that could affect compliance with the protocol or interpretation of results (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
Patients on renal replacement therapy
Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)
New York Heart Association (NYHA) Class III or IV heart failure
Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) > 8500 pg/mL
Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors
Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection
Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

53

Study ID:

NCT05451771

Recruitment Status:

Recruiting

Sponsor:

Rajshekhar Chakraborty, MD

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

New York Presbyterian Hospital/Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Research Nurse Navigator
Contact
212-342-5162
[email protected]
Rajshekhar Chakraborty, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

53

Study ID:

NCT05451771

Recruitment Status:

Recruiting

Sponsor:


Rajshekhar Chakraborty, MD

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.