Trial · NCT03327571

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

NCT03327571, Completed, Takeda; results first posted 2021-06-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes. Trials, record NCT03327571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03327571

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes
NCT number: NCT03327571
Status: Completed
Enrollment: 1,770 participants, actual
Lead sponsor: Takeda
Conditions: Classical Hodgkin Lymphoma, Relapsed or Refractory Classical Hodgkin Lymphoma
First posted: 2017-10-31
Last updated: 2021-06-25
Results first posted: 2021-06-25

Source ClinicalTrials.gov

Registered outcomes72

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Group 2, RRHL: Progression Free Survival (PFS)	From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])	PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by \>=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
Secondary	Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Day 1 at cHL diagnosis	The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 percent \[%\] of body weight over 6 months).
Secondary	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Day 1 at RRHL diagnosis	The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 % of body weight over 6 months).
Secondary	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis	At second, third, fourth, and fifth relapse (up to 9 years 10 months)	The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10% of body weight over 6 months).
Secondary	Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category	Day 1 at cHL diagnosis	IPS score was calculated based on following factors: age \>=45 years, male sex, stage IV disease, albumin\<4 gram per liter (g/L), white blood cell (WBC)\>=15\10\^9 per liter (/L), haemoglobin \<10.5 g/L, and lymphocyte count\<0.6\10\^6/L or \<8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate.
Secondary	Group 1, cHL: Number of Participants With B Symptoms at Diagnosis	Day 1 at cHL diagnosis	The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Secondary	Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis	Day 1 at RRHL diagnosis	The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Secondary	Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment	Day 1 at RRHL diagnosis	Number of participants were categorized based on prior therapies for HL at each line of treatment.
Secondary	Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received	Day 1 at RRHL diagnosis
Secondary	Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens	From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])	Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.

1 to 10 of 72Source ClinicalTrials.gov

See all 72 registered outcomes

Outcomes72

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Group 2, RRHL: Progression Free Survival (PFS)	From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.	months	MEDIAN
SECONDARY	Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Day 1 at cHL diagnosis	The FAS included all participants who were eligible for cHL group including the common participants in both the groups.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Day 1 at RRHL diagnosis	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis	At second, third, fourth, and fifth relapse (up to 9 years 10 months)	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here overall number of participants analyzed are those who were evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category	Day 1 at cHL diagnosis	The FAS included all participants who were eligible for cHL group including the common participants in both the groups. Here overall number of participants analyzed are those who were evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 1, cHL: Number of Participants With B Symptoms at Diagnosis	Day 1 at cHL diagnosis	The FAS included all participants who were eligible for cHL group including the common participants in both the groups.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis	Day 1 at RRHL diagnosis	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment	Day 1 at RRHL diagnosis	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here overall number of participants analyzed are those who were evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received	Day 1 at RRHL diagnosis	The FAS included all participants who were eligible for RRHL group including the common participants in both the groups. Here overall number of participants analyzed are those who were evaluable for this outcome measure.	previous treatment regimen	MEDIAN
SECONDARY	Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens	From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])	The FAS included all participants who were eligible for cHL group including the common participants in both the groups.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 72Source ClinicalTrials.gov

See all 72 outcomes

Results by group680

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Group 2, RRHL: Progression Free Survival (PFS)	Group 2: RRHL		13.17	95% Confidence Interval 9.92 to 20.17	months
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage I-A	0		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage I-B	0		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage II-A	0		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage II-B	441		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage III-A	207		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage III-B	356		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage IV-A	161		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage IV-B	433		Participants
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis	Group 1: cHL	Stage unknown	0		Participants

1 to 10 of 680Source ClinicalTrials.gov

See all 680 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Group 1: cHL	STARTED	Group 1: cHL	1,598
Group 1: cHL	STARTED	Group 2: RRHL	0
Group 1: cHL	COMPLETED	Group 1: cHL	1,598
Group 1: cHL	COMPLETED	Group 2: RRHL	0
Group 1: cHL	NOT COMPLETED	Group 1: cHL	0
Group 1: cHL	NOT COMPLETED	Group 2: RRHL	0
Group 2: RRHL	STARTED	Group 1: cHL	0
Group 2: RRHL	STARTED	Group 2: RRHL	426
Group 2: RRHL	Participants Were Counted in Both Groups	Group 1: cHL	0
Group 2: RRHL	Participants Were Counted in Both Groups	Group 2: RRHL	321

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events1,148

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Neutropenia	Blood and lymphatic system disorders	Group 1: cHL	256	1,598
other	Neutropenia	Blood and lymphatic system disorders	Group 2: RRHL	80	426
other	Leukopenia	Blood and lymphatic system disorders	Group 1: cHL	68	1,598
other	Leukopenia	Blood and lymphatic system disorders	Group 2: RRHL	24	426
other	Febrile neutropenia	Blood and lymphatic system disorders	Group 1: cHL	56	1,598
other	Febrile neutropenia	Blood and lymphatic system disorders	Group 2: RRHL	29	426
other	Anaemia	Blood and lymphatic system disorders	Group 1: cHL	46	1,598
other	Anaemia	Blood and lymphatic system disorders	Group 2: RRHL	20	426
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 1: cHL	27	1,598
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 2: RRHL	20	426

1 to 10 of 1,148Source ClinicalTrials.gov

See all 1,148 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1: cHL	243	1,598
Total, all-cause mortality	Group 2: RRHL	136	426
Total, other adverse events	Group 1: cHL	642	1,598
Total, other adverse events	Group 2: RRHL	187	426
Total, serious adverse events	Group 1: cHL	303	1,598
Total, serious adverse events	Group 2: RRHL	103	426

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36200380	DERIVED	PubMed
40624058	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group 1: cHL vs Group 2: RRHL: deaths from any cause	Trial comparisons
Group 1: cHL vs Group 2: RRHL: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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