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A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03873493
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date May 16, 2019
Estimated Study Start Date  ICMJE August 10, 2019
Estimated Primary Completion Date September 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Overall Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
ORR is defined as the percentage of subjects achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), partial response (PR) or nodular PR (nPR) as their best response (per investigator assessment).
Change History Complete list of historical versions of study NCT03873493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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 ]
    TTP 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, nPR, 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 subjects 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia
Official Title  ICMJE A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • T-cell Prolymphocytic Leukemia (T-PLL)
  • Cancer
Intervention  ICMJE
  • Drug: Venetoclax
    tablet; oral
    Other Names:
    • ABT-199
    • GDC-0199
    • Venclexta
    • Venclyxto
  • Drug: Ibrutinib
    capsule; oral
    Other Name: Imbruvica
Study Arms  ICMJE Experimental: Venetoclax + Ibrutinib
Venetoclax 400 mg, potentially up to 600 mg, orally once daily (QD) plus Ibrutinib 420 mg dosed orally QD.
Interventions:
  • Drug: Venetoclax
  • Drug: Ibrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2023
Estimated Primary Completion Date September 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Austria,   Italy,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873493
Other Study ID Numbers  ICMJE M18-803
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP