Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT03000660
Phase
PHASE1
Status
Terminated

Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax at one of four escalating doses
  • Dexamethasone — DRUG
    Dexamethasone 20mg by mouth on days 1, 8, 15, and 22 of each cycle.

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Aug 2020
Primary completion
Oct 31, 2019
Completion
Oct 10, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax and Dexamethasone
    Venetoclax will be given at one of four escalating doses (100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day) by mouth on each day of the cycle. Dexamethasone will be given at 20mg by mouth on days 1, 8, 15, and 22 of each cycle.

Primary Outcome Measure

Participants with treatment related adverse events using NCI CTCAE version 4.03. [ Time Frame: Up to 8 months after beginning study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111-

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By research site
Tufts Medical Center· Boston, MA

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