Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
M18-803
- SECONDARY ID:
2018-002179-17
- NCT ID:
NCT03873493
Conditions
- Leukemia
- T-cell Prolymphocytic Leukemia (T-PLL)
- Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Venetoclax | ABT-199, GDC-0199, Venclexta, Venclyxto | Venetoclax + Ibrutinib |
| Ibrutinib | Imbruvica | Venetoclax + Ibrutinib |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Venetoclax + Ibrutinib | Experimental | Venetoclax at a predetermined dose according to a prescribed dosing schedule orally once daily (QD) plus Ibrutinib Dose A orally QD. | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall Response Rate (ORR) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Time to Progression (TTP) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Event-free Survival (EFS) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Disease Control Rate (DCR) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | DCR defined as the percentage of participants achieving CR, CRi, PR, or stable disease as best overall response. |
| Measure: | Overall Survival (OS) Rate |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | OS is defined as the time from the date of the participant's first dose of any study drug to death from any cause. |
| Measure: | Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | Number of eligible participants reaching autologous or allogeneic transplantation. |
| Measure: | Number of Participants with Adverse Events (AE) |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | AbbVie |
Trial Keywords
- T-cell Prolymphocytic Leukemia (T-PLL)
- Cancer
- Venetoclax
- Venclexta
- Venclyxto
- Ibrutinib
- Imbruvica
- Relapsed or Refractory T-lymphoid malignancy
Last Updated
April 8, 2021
