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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03873493
Collaborator
(none)
14
Enrollment
15
Locations
1
Arm
21.7
Actual Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
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 :
Jan 14, 2020
Actual Primary Completion Date :
Nov 4, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

ArmIntervention/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 Names:
  • Imbruvica
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [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) [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) [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) [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) [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) [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 [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 [Up to approximately 2 years]

      Number of eligible participants reaching autologous or allogeneic transplantation.

    8. Number of Participants with Adverse Events (AE) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Dana-Farber Cancer Institute /ID# 207728BostonMassachusettsUnited States02215
    2Mayo Clinic - Rochester /ID# 207692RochesterMinnesotaUnited States55905-0001
    3University of Texas MD Anderson Cancer Center /ID# 207746HoustonTexasUnited States77030
    4Peter MacCallum Cancer Ctr /ID# 209554MelbourneVictoriaAustralia3000
    5Medizinische Universitaet Wien /ID# 208497ViennaWienAustria1090
    6Helsinki University Hospital /ID# 208108HelsinkiUusimaaFinland00290
    7HCL - Hôpital Lyon Sud /ID# 208731Pierre Benite CEDEXAuvergne-Rhone-AlpesFrance69495
    8CHRU Lille - Hopital Claude Huriez /ID# 208726LilleHauts-de-FranceFrance59037
    9Hopital Pitie Salpetriere /ID# 208730ParisFrance75013
    10University Hospital Cologne /ID# 208834CologneGermany50937
    11Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487TriesteItaly34128
    12Maxima Medisch Centrum /ID# 207989EindhovenNetherlands5631 BM
    13Universitair Medisch Centrum Groningen /ID# 207990GroningenNetherlands9713 GZ
    14Oxford University Hospitals NHS Foundation Trust /ID# 211264OxfordOxfordshireUnited KingdomOX3 9DU
    15The Royal Marsden NHS Foundation Trust /ID# 211263LondonUnited KingdomSW3 6JJ

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03873493
    Other Study ID Numbers:
    • M18-803
    • 2018-002179-17
    First Posted:
    Mar 13, 2019
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 23, 2021