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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03873493




Registration number
NCT03873493
Ethics application status
Date submitted
12/03/2019
Date registered
13/03/2019

Titles & IDs
Public title
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Scientific 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
Secondary ID [1] 0 0
2018-002179-17
Secondary ID [2] 0 0
M18-803
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
T-cell Prolymphocytic Leukemia (T-PLL) 0 0
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - Ibrutinib

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.


Treatment: Drugs: 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.

Treatment: Drugs: Ibrutinib
Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [3] 0 0
Time to Progression (TTP)
Timepoint [3] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [4] 0 0
Event-free Survival (EFS)
Timepoint [4] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [7] 0 0
Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation
Timepoint [7] 0 0
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Secondary outcome [8] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Timepoint [8] 0 0
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)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2021
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Ctr /ID# 209554 - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Finland
State/province [5] 0 0
Uusimaa
Country [6] 0 0
France
State/province [6] 0 0
Auvergne-Rhone-Alpes
Country [7] 0 0
France
State/province [7] 0 0
Hauts-de-France
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
Germany
State/province [9] 0 0
Cologne
Country [10] 0 0
Italy
State/province [10] 0 0
Trieste
Country [11] 0 0
Netherlands
State/province [11] 0 0
Eindhoven
Country [12] 0 0
Netherlands
State/province [12] 0 0
Groningen
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Oxfordshire
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03873493