A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
NCT ID: NCT03873493
Last Updated: 2022-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2020-01-14
2021-11-04
Brief Summary
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Detailed Description
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Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants.
The study was stopped after Stage 1. Stage 2 was not conducted.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Venetoclax
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
Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Interventions
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Venetoclax
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
Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Received prior alemtuzumab (unless unsuitable or unavailable).
* Has no malignancies other than T-PLL that:
* currently require systemic therapies;
* were not previously treated with curative intention (unless the malignant disease is in a stable remission due to the discretion of the treating physician); or
* developed signs of progression after curative treatment.
Exclusion Criteria
* Has human T-cell lymphotropic virus, type 1.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and requirement for graft versus host therapy.
* Has an uncontrolled or active infection including severe acute respiratory syndrome- coronavirus-2 (SARS-COV-2).
* Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
* Received a prohibited therapy within the specified time frame as described in the protocol.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Dana-Farber Cancer Institute /ID# 207728
Boston, Massachusetts, United States
Mayo Clinic - Rochester /ID# 207692
Rochester, Minnesota, United States
University of Texas MD Anderson Cancer Center /ID# 207746
Houston, Texas, United States
Peter MacCallum Cancer Ctr /ID# 209554
Melbourne, Victoria, Australia
Medizinische Universitaet Wien /ID# 208497
Vienna, Vienna, Austria
Helsinki University Hospital /ID# 208108
Helsinki, Uusimaa, Finland
HCL - Hôpital Lyon Sud /ID# 208731
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHRU Lille - Hopital Claude Huriez /ID# 208726
Lille, Hauts-de-France, France
Hopital Pitie Salpetriere /ID# 208730
Paris, , France
University Hospital Cologne /ID# 208834
Cologne, , Germany
Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487
Trieste, , Italy
Maxima Medisch Centrum /ID# 207989
Eindhoven, , Netherlands
Universitair Medisch Centrum Groningen /ID# 207990
Groningen, , Netherlands
Oxford University Hospitals NHS Foundation Trust /ID# 211264
Oxford, Oxfordshire, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 211263
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2018-002179-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M18-803
Identifier Type: -
Identifier Source: org_study_id