B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes (B-HOLISTIC)

Takeda

Status: Completed

Conditions: Relapsed or Refractory Classical Hodgkin Lymphoma; Classical Hodgkin Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT03327571

CHL-5001

Details and patient eligibility

About

The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.

Full description

This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.

The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

Group 1: cHL Group 2: RRHL

This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).

Enrollment: 1,770 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013.
2. Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
3. Alive or deceased.
4. Written informed consent is obtained for study data collection, where necessary, according to local regulations.

Exclusion criteria

1. Participants for whom the minimum study dataset is not available from their hospital medical records.
2. Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.

Trial design

1,770 participants in 2 patient groups

Group 1: cHL

Description:

Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.

Group 2: RRHL

Description:

Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.