A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AbbVie
Study ID
NCT03873493
Phase
PHASE2
Status
Completed

Conditions

  • Cancer
  • Leukemia
  • T-cell Prolymphocytic Leukemia (T-PLL)

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.
  • Ibrutinib — DRUG
    Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.

Study Details

The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).

Key Dates

Start date
Jan 14, 2020
Status verified
Nov 2022
Primary completion
Nov 4, 2021
Completion
Nov 4, 2021

Study Design

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

Arms

  • Experimental: Venetoclax + Ibrutinib
    Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer Institute /ID# 207728BostonMassachusetts02215-
Mayo Clinic - Rochester /ID# 207692RochesterMinnesota55905-0001-
University of Texas MD Anderson Cancer Center /ID# 207746HoustonTexas77030-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana-Farber Cancer Institute· Boston, MAMayo Clinic - Rochester· Rochester, MNUniversity of Texas MD Anderson Cancer Center· Houston, TX

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