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A Study Evaluating Venetoclax in Subjects With Chronic Lymphocytic Leukemia Whose Cancer Has Come Back or Who Had No Response to Previous Cancer Treatments Including Subjects Missing Part of Their Chromosome 17, or TP53 Gene Mutation; or Who Received Prior Treatment With a B-Cell Receptor Inhibitor

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980731
First Posted: December 2, 2016
Last Update Posted: November 1, 2017
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.
Information provided by (Responsible Party):
AbbVie
  Purpose
The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on the quality of life of participants with chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) including those with the 17p deletion or TP53 mutation (local lab assessed) OR in CLL participants who have received prior B-Cell Receptor Inhibitor (BCRi) therapy. 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 (CLL) Drug: Venetoclax Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of 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 B-Cell Receptor Inhibitor

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [ Time Frame: From Screening (Baseline) up to Week 48 ]
    EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.


Secondary Outcome Measures:
  • Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16), [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]
    EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of HRQoL important in CLL. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." A negative change in score from baseline represents an improvement in symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

  • EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]
    The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health.

  • Change in the remaining subscales/items from the EORTC QLQ-C30. [ Time Frame: From Screening (Baseline; Day 0) up to Week 48 ]
    The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Subjects rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

  • Complete Remission rate (complete remission [CR] + complete remission with incomplete marrow recovery [CRi]) [ Time Frame: When all participants have completed Week 48 disease assessment, or after all enrolled participants have discontinued venetoclax, whichever is earlier. ]
    Complete remission rate (CR + CRi) defined as the proportion of subjects achieving a CR or CRi as their best response (per the investigator assessment) based on IWCLL NCI -WG criteria.

  • Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last participant 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 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group Guidelines (IWCLL NCI-WG) criteria.

  • Duration of Overall Response (DOR) [ Time Frame: Measured up to 2 years after the last participant 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 participant has enrolled in the study. ]
    TPP defined as the number of days from the date of first dose of venetoclax to the date of disease progression.

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

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


Estimated Enrollment: 200
Study Start Date: December 13, 2016
Estimated Study Completion Date: November 15, 2022
Estimated Primary Completion Date: November 11, 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
Tablet
Other Name: ABT-199

  Eligibility

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.


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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • Participant has relapsed/refractory disease (received at least one prior therapy).
  • Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines and:

    • has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines
    • has clinically measurable disease (lymphocytosis > 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 - Adequate bone marrow function.

Exclusion Criteria:

  • Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL).
  • 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.
  • Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids.
  • Prior allogeneic stem cell transplant.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02980731


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

Locations
Argentina
Sanatorio Allende /ID# 150813 Recruiting
Cordoba, Argentina, 5000 JGHQ
Australia
St. George Hospital /ID# 154212 Recruiting
Kogarah, Australia, 2217
Liverpool Hospital /ID# 154950 Recruiting
Liverpool, Australia, 2170
Perth Blood Institute Ltd /ID# 154949 Recruiting
Nedlands, Australia, 6009
Peter MacCallum Cancer Centre /ID# 154948 Recruiting
Parkville, Australia, 3000
Gold Coast University Hospital /ID# 150833 Recruiting
Southport, Australia, 4215
Bulgaria
UMHAT Sv. Georgi EAD /ID# 161594 Not yet recruiting
Plovdiv, Bulgaria, 4002
UMHAT Aleksandrovska /ID# 162987 Not yet recruiting
Sofia, Bulgaria, 1431
UMHAT Sv. Ivan Rilski /ID# 163280 Not yet recruiting
Sofia, Bulgaria, 1431
Hong Kong
Queen Mary Hospital, Univ Hong Kong /ID# 150836 Recruiting
Hong Kong, Hong Kong, 999077
Prince of Wales Hospital /ID# 150837 Not yet recruiting
Shatin, New Territories, Hong Kong, 30-32
Hungary
Szent Laszlo-Szent Istvan Korhaz /ID# 152842 Recruiting
Budapest, Hungary, 1097
Semmelweis Egyetem /ID# 150792 Recruiting
Budapest, Hungary, 1125
New Zealand
North Shore Hospital /ID# 157626 Recruiting
Auckland, New Zealand, 0622
Middlemore Clinical Trials /ID# 161526 Not yet recruiting
Auckland, New Zealand, 2025
Wellington Regional Hospital /ID# 157627 Recruiting
Newtown Wellington, New Zealand, 6021
Poland
SPZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 150877 Recruiting
Chorzow, Poland, 41-500
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat /ID# 150880 Recruiting
Lodz, Poland, 93-510
Instytut Hematologii i Transfuzjilogii /ID# 150878 Recruiting
Warsaw, Poland, 02-776
Russian Federation
FSBSI "N. N. Blokhin Russian Cancer Research Center" /ID# 166610 Recruiting
Moscow, Russian Federation, 115478
Federal State Budgetary Institution /ID# 154213 Recruiting
Moscow, Russian Federation, 125167
State budgetary institution Moscow /ID# 154806 Recruiting
Moscow, Russian Federation, 125284
State Budget Healthcare Institution Regional Oncology Dispe /ID# 154202 Recruiting
Penza, Russian Federation, 440071
Taiwan
China Medical University Hospital /ID# 150839 Recruiting
Taichung City, Taiwan, 404
Taipei Veterans General Hospital /ID# 153803 Recruiting
Taipei City, Taiwan, 11217
National Taiwan University Hospital /ID# 150838 Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Viktor Komlosi, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02980731     History of Changes
Other Study ID Numbers: M15-889
2016-001097-15 ( EudraCT Number )
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Duration of overall response (Dor)
Complete remission rate (CR + CRi)
B-Cell receptor inhibitor (BCRi)
TP53 gene
Progression-free survival (PFS)
European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Refractory CLL
Overall response rate (ORR)
Overall survival (OS)
Relapsed CLL
17p deletion

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
Venetoclax
Receptors, Antigen, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs