Trial · NCT00822120

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

NCT00822120, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2018-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma. Trials, record NCT00822120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00822120

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Trial

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

Title: S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
NCT number: NCT00822120
Status: Completed
Phases: Phase 2
Enrollment: 371 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Lymphoma, Nonneoplastic Condition
Interventions: bleomycin sulfate, filgrastim, ABVD regimen, BEACOPP regimen, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, prednisone, procarbazine hydrochloride, vinblastine sulfate, vincristine sulfate
First posted: 2009-01-14
Last updated: 2022-08-18
Results first posted: 2018-04-04

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Primary	Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS	2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Secondary	Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging	2 years	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Secondary	Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	7 months after registration	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Secondary	Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 1 year	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Secondary	Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Secondary	Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.	5 years	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Secondary	Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	7 months after registration	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Secondary	Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 1 year	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	2 years	Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.	percentage of participants	NUMBER
PRIMARY	Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS	2 years	Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.	percentage of participants	NUMBER
SECONDARY	Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging	2 years	Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.	percentage of participants	NUMBER
SECONDARY	Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	7 months after registration	Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis	percentage of patients	NUMBER
SECONDARY	Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 1 year	Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	2 years	Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.	percentage of patients	NUMBER
SECONDARY	Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.	5 years	Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.	percentage of participants	NUMBER
SECONDARY	Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	7 months after registration	Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Up to 1 year	Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group353

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

Outcome	Group	Category	Value	Spread	Units
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap		79	95% Confidence Interval 74 to 83	percentage of participants
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS	HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP		64	95% Confidence Interval 50 to 75	percentage of participants
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging	HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy		98	95% Confidence Interval 95 to 99	percentage of participants
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	PET-negative: Continued ABVD After 2 Cycles of ABVD		100	95% Confidence Interval 98.6 to 100	percentage of patients
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	PET-positive: BEACOPP Escalated After 2 Cycles of ABVD		93	95% Confidence Interval 82.4 to 97.9	percentage of patients
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	HIV-negative: Initial ABVD	ALT, SGPT (serum glutamic pyruvic transaminase)	3		Participants
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	HIV-negative and PET-negative: Continued ABVD	ALT, SGPT (serum glutamic pyruvic transaminase)	0		Participants
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	HIV-negative and PET-positive: BEACOPP Escalated	ALT, SGPT (serum glutamic pyruvic transaminase)	0		Participants
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	HIV-negative: Initial ABVD	AST, SGOT	1		Participants
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	HIV-negative and PET-negative: Continued ABVD	AST, SGOT	0		Participants

1 to 10 of 353Source ClinicalTrials.gov

See all 353 results by group

Participant flow48

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

Period	Milestone	Group	Participants
Initial Registration	STARTED	HIV-negative: Initial ABVD	358
Initial Registration	STARTED	HIV-positive: Initial ABVD	13
Initial Registration	STARTED	HIV-negative and PET-negative: Continued ABVD	0
Initial Registration	STARTED	HIV-negative and PET-positive: BEACOPP Escalated	0
Initial Registration	STARTED	HIV-positive and PET-negative: Continued ABVD	0
Initial Registration	STARTED	HIV-positive and PET-positive: BEACOPP Standard	0
Initial Registration	Eligible and Evaluable Patients	HIV-negative: Initial ABVD	336
Initial Registration	Eligible and Evaluable Patients	HIV-positive: Initial ABVD	12
Initial Registration	Eligible and Evaluable Patients	HIV-negative and PET-negative: Continued ABVD	0
Initial Registration	Eligible and Evaluable Patients	HIV-negative and PET-positive: BEACOPP Escalated	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events726

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	Febrile neutropenia	Blood and lymphatic system disorders	HIV-negative: Initial ABVD	8	336
other	Febrile neutropenia	Blood and lymphatic system disorders	HIV-negative and PET-negative: Continued ABVD	17	270
other	Febrile neutropenia	Blood and lymphatic system disorders	HIV-negative and PET-positive: BEACOPP Escalated	16	49
other	Febrile neutropenia	Blood and lymphatic system disorders	HIV-positive: Initial ABVD	3	12
other	Febrile neutropenia	Blood and lymphatic system disorders	HIV-positive and PET-negative: Continued ABVD	3	10
other	Febrile neutropenia	Blood and lymphatic system disorders	HIV-positive and PET-positive: BEACOPP Standard	0	1
other	Hemoglobin	Blood and lymphatic system disorders	HIV-negative: Initial ABVD	171	336
other	Hemoglobin	Blood and lymphatic system disorders	HIV-negative and PET-negative: Continued ABVD	161	270
other	Hemoglobin	Blood and lymphatic system disorders	HIV-negative and PET-positive: BEACOPP Escalated	44	49
other	Hemoglobin	Blood and lymphatic system disorders	HIV-positive: Initial ABVD	6	12

1 to 10 of 726Source ClinicalTrials.gov

See all 726 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HIV-negative: Initial ABVD
Total, all-cause mortality	HIV-negative and PET-negative: Continued ABVD
Total, all-cause mortality	HIV-negative and PET-positive: BEACOPP Escalated
Total, all-cause mortality	HIV-positive: Initial ABVD
Total, all-cause mortality	HIV-positive and PET-negative: Continued ABVD
Total, all-cause mortality	HIV-positive and PET-positive: BEACOPP Standard
Total, other adverse events	HIV-negative: Initial ABVD	335	336
Total, other adverse events	HIV-negative and PET-negative: Continued ABVD	268	270
Total, other adverse events	HIV-negative and PET-positive: BEACOPP Escalated	49	49
Total, other adverse events	HIV-positive: Initial ABVD	12	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30723079	DERIVED	PubMed
31331918	DERIVED	PubMed
40135712	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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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