Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
ConditionAL Amyloidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Venetoclax Oral Tablet, 200 mg
- FISH assay
- Venetoclax Oral Tablet, 400 mg
- Dexamethasone Oral, 10 mg
- Dexamethasone Oral, 20 mg
- Daratumumab Injection
- Bendamustine
- Pomalidomide
- Ixazomib
- Venetoclax MTD with Dexamethasone
Treatment groups
53 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Columbia University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov