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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03873493
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : April 8, 2021
Information provided by (Responsible Party):

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Venetoclax + Ibrutinib
Venetoclax at a predetermined dose according to a prescribed dosing schedule orally once daily (QD) plus Ibrutinib Dose A orally QD.
Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta
  • Venclyxto

Drug: Ibrutinib
capsule; oral
Other Name: Imbruvica

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03873493

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Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie Identifier: NCT03873493    
Other Study ID Numbers: M18-803
2018-002179-17 ( EudraCT Number )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
T-cell Prolymphocytic Leukemia (T-PLL)
Relapsed or Refractory T-lymphoid malignancy
Additional relevant MeSH terms:
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Leukemia, Prolymphocytic
Leukemia, Prolymphocytic, T-Cell
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell
Antineoplastic Agents