Hodgkin LymphomaPhase 3HD16NCT00736320
HD16 for Early Stage Hodgkin Lymphoma
A Phase 3 study testing ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) and 20 Gy IFRT (Involved Field Radiotherapy) in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) and 20 Gy IFRT (Involved Field Radiotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin Lymphoma
- CS I, II without risk factors
- large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
- extranodal involvement
- elevated ESR
- 3 or more involved nodal areas
- Written informed consent
Who cannot join
- Leucocytes < 3000/µl
- Platelets < 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity index (WHO) > 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).
- Conditions
- Hodgkin Lymphoma
- Being tested
- ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine), 20 Gy IFRT (Involved Field Radiotherapy)
- Keywords
- Hodgkin Lymphoma, early stage, PET
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)Drug
chemotherapy with 2 cycles of ABVD (day 1 + 15)
20 Gy IFRT (Involved Field Radiotherapy)Radiation
20 Gy Involved Field Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy Receives: Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy) |
| B | Experimental | 2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy Receives: Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 5 years
Secondary outcomes (4)
overall survival
Measured: 5 years
acute toxicity
Measured: 5 years
late toxicity
Measured: 5 years
CR rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startNov 2009
- Primary completionSep 2018
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Engert, University of Cologne
- Investigators
- Andreas Engert, Prof., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736320
- Sponsor's protocol ID
- HD16
- Acronym
- HD16
- Status last verified
- Nov 2020
- First submitted
- 8 Aug 2008
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J. Association between metabolic tumor burden and health-related quality of life in patients with classic Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1847-1855. doi: 10.1007/s00259-025-07569-5. Epub 2025 Oct 11.
PubMed 41074963Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
PubMed 40135712van Heek L, Stuka C, Kaul H, Muller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C. Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial. BMC Cancer. 2022 Jun 18;22(1):672. doi: 10.1186/s12885-022-09758-z.
PubMed 35717166Fuchs M, Goergen H, Kobe C, Kuhnert G, Lohri A, Greil R, Sasse S, Topp MS, Schafer E, Hertenstein B, Soekler M, Vogelhuber M, Zijlstra JM, Keller UB, Krause SW, Wilhelm M, Maschmeyer G, Thiemer J, Duhrsen U, Meissner J, Viardot A, Eich H, Baues C, Diehl V, Rosenwald A, von Tresckow B, Dietlein M, Borchmann P, Engert A. Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group. J Clin Oncol. 2019 Nov 1;37(31):2835-2845. doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10.
PubMed 31498753Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
PubMed 30010775Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. doi: 10.6004/jnccn.2015.0077.
PubMed 25964643
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
- ClinicalTrials.gov ID
- NCT00736320
- Acronym / sponsor ID
- HD16 / HD16
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, early stage, PET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine), Radiation: 20 Gy IFRT (Involved Field Radiotherapy)2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy |
| B | Experimental | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine), Radiation: 20 Gy IFRT (Involved Field Radiotherapy)2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hodgkin Lymphoma
- CS I, II without risk factors
- Written informed consent
Key exclusion criteria (4 listed)
- Leucocytes < 3000/µl
- Platelets < 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity index (WHO) > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)chemotherapy with 2 cycles of ABVD (day 1 + 15) | Drug | A, B |
| 20 Gy IFRT (Involved Field Radiotherapy)20 Gy Involved Field Radiotherapy | Radiation | A, B |
Primary outcome
Progression Free Survival
Time frame: 5 years
4 secondary outcomes
overall survival
Time frame: 5 years
acute toxicity
Time frame: 5 years
late toxicity
Time frame: 5 years
CR rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 41074963Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J. Association between metabolic tumor burden and health-related quality of life in patients with classic Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1847-1855. doi: 10.1007/s00259-025-07569-5. Epub 2025 Oct 11.
- Derived from this study: PubMed 40135712Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
- Derived from this study: PubMed 35717166van Heek L, Stuka C, Kaul H, Muller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C. Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial. BMC Cancer. 2022 Jun 18;22(1):672. doi: 10.1186/s12885-022-09758-z.
- Derived from this study: PubMed 31498753Fuchs M, Goergen H, Kobe C, Kuhnert G, Lohri A, Greil R, Sasse S, Topp MS, Schafer E, Hertenstein B, Soekler M, Vogelhuber M, Zijlstra JM, Keller UB, Krause SW, Wilhelm M, Maschmeyer G, Thiemer J, Duhrsen U, Meissner J, Viardot A, Eich H, Baues C, Diehl V, Rosenwald A, von Tresckow B, Dietlein M, Borchmann P, Engert A. Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group. J Clin Oncol. 2019 Nov 1;37(31):2835-2845. doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10.
- Derived from this study: PubMed 30010775Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
- Derived from this study: PubMed 25964643Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. doi: 10.6004/jnccn.2015.0077.
- Homepage GHSGLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Engert, Prof. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) and 20 Gy IFRT (Involved Field Radiotherapy) in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736320, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.