A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT03873493|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : April 8, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia T-cell Prolymphocytic Leukemia (T-PLL) Cancer||Drug: Venetoclax Drug: Ibrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 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|
|Actual Study Start Date :||January 14, 2020|
|Estimated Primary Completion Date :||September 13, 2022|
|Estimated Study Completion Date :||September 13, 2022|
Experimental: Venetoclax + Ibrutinib
Venetoclax at a predetermined dose according to a prescribed dosing schedule orally once daily (QD) plus Ibrutinib Dose A 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 date of first dose of any study drug to the date of earliest disease progression or death.
- Duration of Response (DOR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 2 years ]Number of eligible participants reaching autologous or allogeneic transplantation.
- Number of Participants with Adverse Events (AE) [ Time Frame: 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.
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
|Study Director:||AbbVie Inc.||AbbVie|