Back to resultsA Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Primary Purpose
Leukemia, T-cell Prolymphocytic Leukemia (T-PLL), Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring T-cell Prolymphocytic Leukemia (T-PLL), Cancer, Venetoclax, Venclexta, Venclyxto, Ibrutinib, Imbruvica, Relapsed or Refractory T-lymphoid malignancy
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.
Sites / Locations
- Dana-Farber Cancer Institute /ID# 207728
- Mayo Clinic - Rochester /ID# 207692
- University of Texas MD Anderson Cancer Center /ID# 207746
- Peter MacCallum Cancer Ctr /ID# 209554
- Medizinische Universitaet Wien /ID# 208497
- Helsinki University Hospital /ID# 208108
- HCL - Hôpital Lyon Sud /ID# 208731
- CHRU Lille - Hopital Claude Huriez /ID# 208726
- Hopital Pitie Salpetriere /ID# 208730
- University Hospital Cologne /ID# 208834
- Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487
- Maxima Medisch Centrum /ID# 207989
- Universitair Medisch Centrum Groningen /ID# 207990
- Oxford University Hospitals NHS Foundation Trust /ID# 211264
- The Royal Marsden NHS Foundation Trust /ID# 211263
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venetoclax + Ibrutinib
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019.
CR: All of the following response criteria must be met:
Group A:
all lymph nodes < 1 cm;
spleen < 13 cm;
no constitutional symptoms;
circulating lymphocyte count < 4 × 10^9/L;
bone marrow T-PLL cells < 5% of mononuclear cells;
no other specific site involvement
Group B:
platelets ≥ 100 × 10^9 /L;
hemoglobin ≥ 11.0 g/dL;
neutrophils ≥ 1.5 × 10^9 /L.
CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity.
PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.
Secondary Outcome Measures
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods.
Response was assessed by the investigator based on the T-PLL consensus criteria 2019.
Progressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Duration of Response (DOR)
Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods.
Response was assessed by the investigator based on the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Time to Progression (TTP)
Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods.
Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Event-free Survival (EFS)
Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods.
Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019.
Stable disease is defined as meeting all of the following criteria for at least 3 months:
lymph nodes change of -29% to +20% in SLD;
spleen change of -49% to +49% beyond normal from baseline;
circulating lymphocyte count > 30 × 10^9 /L or change of -49% to +49%;
platelet count change of -49% to +49%;
hemoglobin < 11.0 g/dL or change < 50% from baseline or change < 2 g/dL;
neutrophils change of -49% to +49%.
Overall Survival (OS)
Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods.
Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation
Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.
Number of Participants With Treatment-emergent Adverse Events (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug.
A serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome.
The Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.
The Investigator assessed the relationship of the AE to the use of study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03873493
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venetoclax + Ibrutinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, Venclexta®, Venclyxto®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica®
Intervention Description
Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019.
CR: All of the following response criteria must be met:
Group A:
all lymph nodes < 1 cm;
spleen < 13 cm;
no constitutional symptoms;
circulating lymphocyte count < 4 × 10^9/L;
bone marrow T-PLL cells < 5% of mononuclear cells;
no other specific site involvement
Group B:
platelets ≥ 100 × 10^9 /L;
hemoglobin ≥ 11.0 g/dL;
neutrophils ≥ 1.5 × 10^9 /L.
CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity.
PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.
Time Frame
Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods.
Response was assessed by the investigator based on the T-PLL consensus criteria 2019.
Progressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Duration of Response (DOR)
Description
Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods.
Response was assessed by the investigator based on the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Time to Progression (TTP)
Description
Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods.
Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Event-free Survival (EFS)
Description
Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods.
Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019.
Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below:
Group A:
lymph nodes increase in > 20% in SLD from nadir;
spleen increase ≥ 50% in vertical length beyond normal from baseline;
circulating lymphocyte count increase ≥ 50% from baseline;
appearance of a new lesion;
Group B:
platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity);
hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL;
neutrophils decrease of ≥ 50% from baseline due to T-PLL.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019.
Stable disease is defined as meeting all of the following criteria for at least 3 months:
lymph nodes change of -29% to +20% in SLD;
spleen change of -49% to +49% beyond normal from baseline;
circulating lymphocyte count > 30 × 10^9 /L or change of -49% to +49%;
platelet count change of -49% to +49%;
hemoglobin < 11.0 g/dL or change < 50% from baseline or change < 2 g/dL;
neutrophils change of -49% to +49%.
Time Frame
Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation
Description
Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.
Time Frame
From first dose of study drug to end of study; median time on study was 30.1 weeks.
Title
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug.
A serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome.
The Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.
The Investigator assessed the relationship of the AE to the use of study drug.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Dana-Farber Cancer Institute /ID# 207728
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 207692
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 207746
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Peter MacCallum Cancer Ctr /ID# 209554
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Medizinische Universitaet Wien /ID# 208497
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Helsinki University Hospital /ID# 208108
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Facility Name
HCL - Hôpital Lyon Sud /ID# 208731
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 208726
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Pitie Salpetriere /ID# 208730
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
University Hospital Cologne /ID# 208834
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487
City
Trieste
ZIP/Postal Code
34128
Country
Italy
Facility Name
Maxima Medisch Centrum /ID# 207989
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 207990
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 211264
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust /ID# 211263
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
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