Nüks Etmiş (Kanserin Geri Gelmesi) veya Dirençli (Önceki Kanser Tedavilerine Yanıt Vermeyen) Kronik Lenfositik Lösemi (CLL) Olan Kişilerde Venetoclax Monoterapisinin Yaşam Kalitesine Etkisini Değerlendiren Bir Çalışma

Sade dilde özet

Bu çalışma, nüks etmiş ya da tedaviye dirençli kronik lenfositik lösemi (chronic lymphocytic leukemia, CLL) olan kişilerde tek başına Venetoclax tedavisinin yaşam kalitesi üzerindeki etkisini değerlendirmektedir. Çalışmaya, en az bir önceki tedaviyi almış, ölçülebilir hastalığı olan CLL hastaları alınmıştır. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

AbbVie

Müdahale

Venetoclax

Başlangıç

13.12.2016

Tahmini bitiş

29.12.2021

Ülkeler

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

İlgili genler

Merkezler

• 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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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