Clinical Trials /

A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia

NCT03873493

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 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.

Related Conditions:
  • T-Cell Prolymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects 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

DrugSynonymsArms
VenetoclaxABT-199, GDC-0199, Venclexta, VenclyxtoVenetoclax + Ibrutinib
IbrutinibImbruvicaVenetoclax + 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 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.

Trial Arms

NameTypeDescriptionInterventions
Venetoclax + IbrutinibExperimentalVenetoclax 400 mg, potentially up to 600 mg, orally once daily (QD) plus Ibrutinib 420 mg dosed orally QD.
  • Venetoclax
  • Ibrutinib

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.

          -  Negative for human T-cell lymphotropic virus, type 1.

          -  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.

          -  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 participant's first dose of study drug to the date of documented 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 study drug to the date of documented disease progression; does not include deaths.
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:DOR defined as the time from the date of first response (CR, CRi, or PR) to the date of disease progression.
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 study drug to to the date of death from any cause.
Measure:Number of Participants Reaching Autologous or Allogeneic Transplantation
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Number of participants reaching autologous or allogeneic transplantation.
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 study drug to disease progression, death, or discontinuation of treatment for any reason.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • T-cell Prolymphocytic Leukemia (T-PLL)
  • Cancer
  • venetoclax
  • ibrutinib
  • Relapsed or Refractory T-lymphoid malignancy

Last Updated

November 4, 2019