NCT03873493

Brief Summary

The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2 leukemia

Geographic Reach
8 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2022

Completed
Last Updated

December 19, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

March 12, 2019

Results QC Date

October 27, 2022

Last Update Submit

November 23, 2022

Conditions

LeukemiaT-cell Prolymphocytic Leukemia (T-PLL)Cancer

Keywords

T-cell Prolymphocytic Leukemia (T-PLL)CancerVenetoclaxVenclextaVenclyxtoIbrutinibImbruvicaRelapsed or Refractory T-lymphoid malignancy

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019. CR: All of the following response criteria must be met: Group A: * all lymph nodes \< 1 cm; * spleen \< 13 cm; * no constitutional symptoms; * circulating lymphocyte count \< 4 × 10\^9/L; * bone marrow T-PLL cells \< 5% of mononuclear cells; * no other specific site involvement Group B: * platelets ≥ 100 × 10\^9 /L; * hemoglobin ≥ 11.0 g/dL; * neutrophils ≥ 1.5 × 10\^9 /L. CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity. PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.

    Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment

Secondary Outcomes (8)

  • Progression-Free Survival (PFS)

    From first dose of study drug to end of study; median time on study was 30.1 weeks.

  • Duration of Response (DOR)

    From first dose of study drug to end of study; median time on study was 30.1 weeks.

  • Time to Progression (TTP)

    From first dose of study drug to end of study; median time on study was 30.1 weeks.

  • Event-free Survival (EFS)

    From first dose of study drug to end of study; median time on study was 30.1 weeks.

  • Disease Control Rate (DCR)

    Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment

  • +3 more secondary outcomes

Study Arms (1)

Venetoclax + Ibrutinib

EXPERIMENTAL

Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.

Drug: VenetoclaxDrug: Ibrutinib

Interventions

VenetoclaxDRUG

Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.

Also known as: ABT-199, GDC-0199, Venclexta®, Venclyxto®
Venetoclax + Ibrutinib
IbrutinibDRUG

Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.

Also known as: Imbruvica®
Venetoclax + Ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Dana-Farber Cancer Institute /ID# 207728

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic - Rochester /ID# 207692

Rochester, Minnesota, 55905-0001, United States

Location

University of Texas MD Anderson Cancer Center /ID# 207746

Houston, Texas, 77030, United States

Location

Peter MacCallum Cancer Ctr /ID# 209554

Melbourne, Victoria, 3000, Australia

Location

Medizinische Universitaet Wien /ID# 208497

Vienna, Vienna, 1090, Austria

Location

Helsinki University Hospital /ID# 208108

Helsinki, Uusimaa, 00290, Finland

Location

HCL - Hôpital Lyon Sud /ID# 208731

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 208726

Lille, Hauts-de-France, 59037, France

Location

Hopital Pitie Salpetriere /ID# 208730

Paris, 75013, France

Location

University Hospital Cologne /ID# 208834

Cologne, 50937, Germany

Location

Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487

Trieste, 34128, Italy

Location

Maxima Medisch Centrum /ID# 207989

Eindhoven, 5631 BM, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 207990

Groningen, 9713 GZ, Netherlands

Location

Oxford University Hospitals NHS Foundation Trust /ID# 211264

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

The Royal Marsden NHS Foundation Trust /ID# 211263

London, SW3 6JJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Prolymphocytic, T-CellNeoplasmsRecurrence

Interventions

venetoclaxibrutinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, ProlymphocyticLeukemia, LymphoidLeukemia, T-CellLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 13, 2019

Study Start

January 14, 2020

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

December 19, 2022

Results First Posted

December 19, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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, analyses plans, 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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
More information

Locations

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