A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT03873493|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : May 16, 2019
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 up to 14 participants and move to Stage 2 if 4 or more subjects 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 with previously untreated or relapsed or refractory T-PLL.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia T-cell Prolymphocytic Leukemia (T-PLL) Cancer||Drug: Venetoclax Drug: Ibrutinib||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||August 10, 2019|
|Estimated Primary Completion Date :||September 21, 2022|
|Estimated Study Completion Date :||September 15, 2023|
Experimental: Venetoclax + Ibrutinib
Venetoclax 400 mg, potentially up to 600 mg, orally once daily (QD) plus Ibrutinib 420 mg dosed orally QD.
Other Name: Imbruvica
- Overall Response Rate (ORR) [ Time Frame: 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).
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]PFS is defined as the time from the participant's first dose of study drug to the date of documented disease progression, or death.
- Time to Progression (TTP) [ Time Frame: Up to approximately 2 years ]TPP is defined as the time from the date of the participant's first dose of study drug to the date of documented disease progression; does not include deaths.
- Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]DOR defined as the time from the date of first response (CR, CRi, or PR) to the date of disease progression.
- Overall Survival (OS) Rate [ Time Frame: Up to approximately 2 years ]OS is defined as the time from the date of the participant's first dose of study drug to to the date of death from any cause.
- Number of Participants Reaching Autologous or Allogeneic Transplantation [ Time Frame: Up to approximately 2 years ]Number of participants reaching autologous or allogeneic transplantation.
- Event-free Survival (EFS) [ Time Frame: Up to approximately 2 years ]EFS is defined as time from participant's first dose of study drug to disease progression, death, or discontinuation of treatment for any reason.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873493
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
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|Study Director:||AbbVie Inc.||AbbVie|