A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).

Plain-language summary

This study evaluates how Venetoclax given on its own (monotherapy) affects quality of life in people with relapsed or refractory chronic lymphocytic leukemia (CLL). It enrolled CLL patients with measurable disease who had received at least one prior therapy. The study was carried out in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

AbbVie

Intervention

Venetoclax

Start date

12/13/2016

Estimated completion

12/29/2021

Countries

Argentina, Australia, Bulgaria, Hong Kong, Hungary, Mexico, New Zealand, Poland, Russia, Taiwan

Related genes

Locations

• La Plata, Argentina
• Ciudad Autonoma de Buenos Aire, Argentina
• Ciudad Autonoma de Buenos Aire, Argentina
• Córdoba, Argentina
• Kogarah, Australia
• Liverpool, Australia
• Southport, Australia
• Melbourne, Australia
• Nedlands, Australia
• Sofiya, Bulgaria
• Plovdiv, Bulgaria
• Sofia, Bulgaria
• Sofia, Bulgaria
• Hong Kong, Hong Kong
• Hong Kong, Hong Kong
• Budapest, Hungary
• Budapest, Hungary
• Morelia, Mexico
• Monterrey, Mexico
• Papatoetoe, New Zealand
• Takapuna, New Zealand
• Newtown, New Zealand
• Warsaw, Poland
• Gdynia, Poland
• Chorzów, Poland
• Lodz, Poland
• Moscow, Russia
• Moscow, Russia
• Penza, Russia
• Moscow, Russia
• Taichung, Taiwan
• Taipei, Taiwan
• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 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 × 10\^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
  * with or without 17p deletion or TP53 mutation
  * may have been previously treated with a prior B-cell receptor inhibitor therapy
* 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