Clinical trial NCT03873493: A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Official title: A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
T-cell Prolymphocytic Leukemia (T-PLL)
Cancer
Keywords: T-cell Prolymphocytic Leukemia (T-PLL)
Cancer
Venetoclax
Venclexta
Venclyxto
Ibrutinib
Imbruvica
Relapsed or Refractory T-lymphoid malignancy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This study is planned as an adaptive 2-stage design as follows:

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Duration of Response (DOR)
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Time to Progression (TTP)
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Event-free Survival (EFS)
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Disease Control Rate (DCR)
timeFrame: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment
measure: Overall Survival (OS)
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation
timeFrame: From first dose of study drug to end of study; median time on study was 30.1 weeks.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 207728
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 207692
state: Minnesota
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 207746
state: Texas
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Ctr /ID# 209554
state: Victoria
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 208497
state: Wien
city: Helsinki
country: Finland
facility: Helsinki University Hospital /ID# 208108
state: Uusimaa
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 208731
state: Auvergne-Rhone-Alpes
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 208726
state: Hauts-de-France
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 208730
city: Cologne
country: Germany
facility: University Hospital Cologne /ID# 208834
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum /ID# 207989
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 207990
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 211264
state: Oxfordshire
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust /ID# 211263
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: