A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
A study to evaluate the safety and efficacy of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 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.
Arms and Interventions
|Experimental: Venetoclax + Ibrutinib|
Venetoclax at a predetermined dose according to a prescribed dosing schedule orally once daily (QD) plus Ibrutinib Dose A orally QD.
Primary Outcome Measures
- Overall Response Rate (ORR) [Up to approximately 2 years]
ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) as their best response (per investigator assessment).
Secondary Outcome Measures
- Progression-Free Survival (PFS) [Up to approximately 2 years]
PFS is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death.
- Duration of Response (DOR) [Up to approximately 2 years]
DOR defined for participants who achieve 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.
- Time to Progression (TTP) [Up to approximately 2 years]
TPP 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.
- Event-free Survival (EFS) [Up to approximately 2 years]
EFS 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.
- Disease Control Rate (DCR) [Up to approximately 2 years]
DCR defined as the percentage of participants achieving CR, CRi, PR, or stable disease as best overall response.
- Overall Survival (OS) Rate [Up to approximately 2 years]
OS is defined as the time from the date of the participant's first dose of any study drug to death from any cause.
- Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation [Up to approximately 2 years]
Number of eligible participants reaching autologous or allogeneic transplantation.
- Number of Participants with Adverse Events (AE) [Up to approximately 2 years]
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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.
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.
Contacts and Locations
|1||Dana-Farber Cancer Institute /ID# 207728||Boston||Massachusetts||United States||02215|
|2||Mayo Clinic - Rochester /ID# 207692||Rochester||Minnesota||United States||55905-0001|
|3||University of Texas MD Anderson Cancer Center /ID# 207746||Houston||Texas||United States||77030|
|4||Peter MacCallum Cancer Ctr /ID# 209554||Melbourne||Victoria||Australia||3000|
|5||Medizinische Universitaet Wien /ID# 208497||Vienna||Wien||Austria||1090|
|6||Helsinki University Hospital /ID# 208108||Helsinki||Uusimaa||Finland||00290|
|7||HCL - Hôpital Lyon Sud /ID# 208731||Pierre Benite CEDEX||Auvergne-Rhone-Alpes||France||69495|
|8||CHRU Lille - Hopital Claude Huriez /ID# 208726||Lille||Hauts-de-France||France||59037|
|9||Hopital Pitie Salpetriere /ID# 208730||Paris||France||75013|
|10||University Hospital Cologne /ID# 208834||Cologne||Germany||50937|
|11||Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487||Trieste||Italy||34128|
|12||Maxima Medisch Centrum /ID# 207989||Eindhoven||Netherlands||5631 BM|
|13||Universitair Medisch Centrum Groningen /ID# 207990||Groningen||Netherlands||9713 GZ|
|14||Oxford University Hospitals NHS Foundation Trust /ID# 211264||Oxford||Oxfordshire||United Kingdom||OX3 9DU|
|15||The Royal Marsden NHS Foundation Trust /ID# 211263||London||United Kingdom||SW3 6JJ|
Sponsors and Collaborators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)None provided.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.