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

Completed · Phase 2

Conditions studied: Leukemia, T-cell Prolymphocytic Leukemia (T-PLL), Cancer

In brief

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 facts

Study ID

NCT03873493

Run by

AbbVie

People needed

14

Starts

2020-01-14

Expected to finish

2021-11-04

Last updated by the study team

2022-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate liver, kidney and hematology function per laboratory values as described in the protocol.
• 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.

You may not qualify if…

• History of or current decompensated cirrhosis including Child-Pugh class B or C, ascites, hepatic encephalopathy, or variceal bleeding.
• 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.

Where it is running

• 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, State of 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

Full record on ClinicalTrials.gov

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