N/A
N=1,598
B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes
Classical Hodgkin Lymphoma · Relapsed or Refractory Classical Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03327571 ↗Enrolled (actual)
1,598
Serious AEs
20.1%
Results posted
Jun 2021
Primary outcome: Primary: Group 2, RRHL: Progression Free Survival (PFS) — 13.17 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Group 2, RRHL: Progression Free Survival (PFS) |
13.17 | — |
| SECONDARY Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis |
0; 0; 0; 441; 207; 356 | — |
| SECONDARY Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis |
7; 2; 24; 61; 52; 78 | — |
| SECONDARY Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis |
1; 0; 6; 9; 9; 15 | — |
| SECONDARY Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category |
289; 504; 294 | — |
| SECONDARY Group 1, cHL: Number of Participants With B Symptoms at Diagnosis |
1230; 368 | — |
| SECONDARY Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis |
248; 178 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment |
425; 17; 1; 1 | — |
| SECONDARY Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received |
1.0 | — |
| SECONDARY Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens |
1363; 1; 2; 9; 11; 3 | — |
| SECONDARY Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen |
6.0; 5.0; 6.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse) |
2; 1; 8; 15; 8; 6 | — |
| SECONDARY Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline |
10; 244; 94; 60; 1; 8 | — |
| SECONDARY Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease |
225; 115 | — |
| SECONDARY Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment |
68.7; 31.3; 7.6; 60.0; 73.5; 26.5 | — |
| SECONDARY Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT |
6.0; 8.0; 2.0; 3.0; 5.0; 4.0 | — |
| SECONDARY Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible |
21; 3; 13; 1; 11; 2 | — |
| SECONDARY Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility |
12; 13; 19; 1; 11; 5 | — |
| SECONDARY Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment |
161; 1; 1; 4; 1; 1 | — |
| SECONDARY Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative |
2.6; 43.6 | — |
| SECONDARY Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway |
31.4; 59.3; 50 | — |
| SECONDARY Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway |
17.4; 22.9 | — |
| SECONDARY Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants |
1.0; 1.0; 1.0 | — |
| SECONDARY Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants |
6.0; 6.0; 6.0; 3.0; 4.0; 3.0 | — |
| SECONDARY Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants |
5.4; 2.2; 2.1; 9.7 | — |
| SECONDARY Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment |
14.3; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants |
24.0 | — |
| SECONDARY Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants |
33.0; 36.5 | — |
| SECONDARY Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline |
1; 19; 9; 10; 2; 3 | — |
| SECONDARY Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory |
0; 24; 20; 10; 1; 2 | — |
| SECONDARY Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants |
36.0; 30.5 | — |
| SECONDARY Group 2, RRHL: Number of PET or CT Scan Assessments |
1.1; 1.4; 2.0 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT |
1; 2; 1; 5; 3; 1 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT |
19; 81; 47; 83; 63; 73 | — |
| SECONDARY Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT |
3.0; 5.5; 3.0; 3.0; 2.0; 3.0 | — |
| SECONDARY Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT |
1.4 | — |
| SECONDARY Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT |
11.1 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT |
36; 182 | — |
| SECONDARY Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT |
182.5 | — |
| SECONDARY Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT |
211.2 | — |
| SECONDARY Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT |
9.9 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT |
57; 1; 1; 1; 4; 2 | — |
| SECONDARY Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens |
12.5; 12.5; 12.5; 12.5; 12.5; 12.5 | — |
| SECONDARY Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT |
6.0; 2.0; 2.0; 2.0; 6.0; 7.0 | — |
| SECONDARY Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT |
5.9; 2.0; 2.0; 0.2; 7.2; 4.0 | — |
| SECONDARY Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT |
16.0 | — |
| SECONDARY Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT |
16.0; 19.1; 28.1; 63.0; 87.0 | — |
| SECONDARY Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT |
23.6; 54.5; 60.0; 47.9; 60.4; 70.8 | — |
| SECONDARY Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT |
1.0; 2.0; 5.6; 1.0; 2.6; 4.3 | — |
| SECONDARY Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT |
1; 8; 4; 2; 1; 21 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory |
1; 1; 4; 2; 7; 4 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT |
14; 1; 23; 5; 2 | — |
| SECONDARY Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT |
32.0; 33.0 | — |
| SECONDARY Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT) |
38.1; 4.8 | — |
| SECONDARY Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT |
1.0 | — |
| SECONDARY Group 1, cHL: Median PFS |
NA | — |
| SECONDARY Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment |
968; 356; 80; 109; 85 | — |
| SECONDARY Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment |
131; 133; 40; 98; 24; 107 | — |
| SECONDARY Mean Duration of Best Response |
NA; 51.08 | — |
| SECONDARY Median Overall Survival (OS) |
NA; NA | — |
| SECONDARY Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years |
95.65; 84.74 | — |
| SECONDARY Group 2, RRHL: Overall Survival Rate at 1 and 5 Years |
89.15; 70.68 | — |
| SECONDARY Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL |
864; 357; 1135 | — |
| SECONDARY Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL |
563; 39; 146; 287; 37; 384 | — |
| SECONDARY Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL |
15.1; 13.2; 20.2; 28.0; 32.7 | — |
| SECONDARY Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL |
357; 427; 92; 273; 19; 997 | — |
| SECONDARY Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment |
5.6; 2.5 | — |
| SECONDARY Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT |
175; 44; 185; 5; 2; 4 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT |
144; 6; 50; 36; 6; 51 | — |
| SECONDARY Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT |
13.6; 11.4; 25.8; 13.0; 25.8; 7.8 | — |
| SECONDARY Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT |
63; 8; 19; 3; 43; 4 | — |
| SECONDARY Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT |
2.8; 2.6; 4.2; 6.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
- Alive or deceased.
- Written informed consent is obtained for study data collection, where necessary, according to local regulations.
Exclusion Criteria
- Participants for whom the minimum study dataset is not available from their hospital medical records.
- Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.
Data sourced from ClinicalTrials.gov (NCT03327571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.