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Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting

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AbbVie

Status

Active, not recruiting

Conditions

Chronic Lymphocytic Leukemia (CLL)

Study type

Observational

Funder types

Industry

Identifiers

NCT03342144
P17-132

Details and patient eligibility

About

An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab or obinutuzumab as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participant with chronic lymphocytic leukemia (CLL) administering venetoclax and who meets the following conditions as specified in the label for venetoclax:
  • Venetoclax monotherapy for the treatment of CLL in the presence of deletion chromosome 17 (del[17p]) or tumor protein p53 (TP53) mutation in adult participants, who are unsuitable for or have failed to a B-cell receptor pathway inhibitor.
  • Venetoclax monotherapy for the treatment of CLL in the absence of del(17p) or TP53 mutation in adult participants, who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
  • Venetoclax in combination with rituximab for the treatment of adult participants with CLL who have received at least one prior therapy.
  • Venetoclax in combination with obinutuzumab for previously untreated adult participants with CLL.

Exclusion criteria

  • None

Trial design

350 participants in 3 patient groups

Participants Receiving Venetoclax
Description:
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Description:
Participants with CLL receiving venetoclax in combination with rituximab.
Participants Receiving Venetoclax + Obinutuzumab
Description:
Participants with CLL receiving venetoclax in combination with obinutuzumab.

Trial contacts and locations

59

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Data sourced from clinicaltrials.gov

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