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Trial record 1 of 1 for:    NCT02756611
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A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor.

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02756611
First received: April 26, 2016
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax monotherapy in approximately 250 participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Venetoclax
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Open-Label, Single-Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT-199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) Including Those With the 17p Deletion or TP53 Mutation OR Those Who Have Received Prior Treatment With a B-Cell Receptor Inhibitor

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Complete Remission Rate (CR + CRi) as assessed by the investigator [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    The proportion of participants achieving a CR or CRi as their best response (per the investigator assessment) based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    ORR assessed as the proportion of participants with an overall response (CR + CRi + Nodular Partial Remission [nPR] + Partial Remission [PR]) based on the IWCLL NCI-WG criteria.

  • Duration of Overall Response (DoR) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the earliest recurrence or progressive disease.

  • Time to Progression (TTP) [ Time Frame: Measured up to 2 years after the last subject has enrolled in the study. ]
    TTP is defined as the number of days from the date of first dose or enrollment if not dosed to the date of earliest disease progression.

  • Progression-Free Survival (PFS) [ Time Frame: Measured up to 2 years after the last subject has enrolled into the study. ]
    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.

  • Overall Survival (OS) [ Time Frame: Measured up to 2 years after the last subject has enrolled into the study. ]
    OS is defined as number of days from the date of first dose to the date of death for all dosed subjects.

  • CR Rate (CR + CRi) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    CR + CRi in previously treated B-Cell receptor inhibitor (BCRi) subjects assessed based on the 2008 Modified IWCLL NCI-WG criteria.

  • Rate of Minimal Residual Disease (MRD) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    The rate is defined as the proportion of participants who had MRD negativity status.


Other Outcome Measures:
  • Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) [ Time Frame: Up to Week 108 ]
    The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess patient health-related quality of life (HRQoL) and leukemia-specific symptoms.

  • Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) [ Time Frame: Up to Week 108 ]
    The FACIT-F questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-F has 13 items answered on a 5-point rating scale based on a 7-day recall period.

  • EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: Up to Week 108 ]
    Five items in the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) are rated on 5 levels of severity.


Estimated Enrollment: 250
Study Start Date: March 2016
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venetoclax
Venetoclax will be administered orally 20 mg once daily (QD) beginning with a dose-titration phase, and then escalated up to 400 mg QD.
Drug: Venetoclax
Tablets
Other Name: ABT-199

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
  • Participant has relapsed/refractory disease (received at least 1 prior therapy)
  • Participant has diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG Guidelines and:

    • has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
    • has clinically measurable disease (lymphocytosis greater than 5 × 109/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
  • In addition, participants:

    • may harbor 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood AND/OR
    • may have been previously treated with a prior B-cell receptor inhibitor
  • Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria:

  • Participant has developed Richter's transformation or Prolymphocytic leukemia
  • Participant has previously received venetoclax
  • History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:

    • adequately treated in situ carcinoma of the cervix uteri
    • adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
    • previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
  • Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
  • Participant has undergone an allogeneic stem cell transplant grade 2:

    • Any anti-cancer therapy including chemotherapy, or radiotherapy;
    • Investigational therapy, including targeted small molecule agents
  • Participant is human immunodeficiency virus (HIV) positive
  • Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02756611

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Show 56 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Viktor Komlosi, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02756611     History of Changes
Other Study ID Numbers: M15-550
2015-003667-11 ( EudraCT Number )
Study First Received: April 26, 2016
Last Updated: April 13, 2017

Keywords provided by AbbVie:
Oncology
TP53 Mutation
Refractory
Relapsed
B-Cell receptor inhibitor
17p Deletion
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Receptors, Antigen, B-Cell
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 25, 2017