HD16 for Early Stage Hodgkin Lymphoma

NCT ID: NCT00736320

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2021-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy

Group Type ACTIVE_COMPARATOR

ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)

Intervention Type DRUG

chemotherapy with 2 cycles of ABVD (day 1 + 15)

20 Gy IFRT (Involved Field Radiotherapy)

Intervention Type RADIATION

20 Gy Involved Field Radiotherapy

B

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

Group Type EXPERIMENTAL

ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)

Intervention Type DRUG

chemotherapy with 2 cycles of ABVD (day 1 + 15)

20 Gy IFRT (Involved Field Radiotherapy)

Intervention Type RADIATION

20 Gy Involved Field Radiotherapy

Interventions

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ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)

chemotherapy with 2 cycles of ABVD (day 1 + 15)

Intervention Type DRUG

20 Gy IFRT (Involved Field Radiotherapy)

20 Gy Involved Field Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity index (WHO) \> 2
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Engert

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Engert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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1st Dept. of Medicine, Cologne University Hospital

Cologne, , Germany

Site Status

Countries

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Germany

References

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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. 2025 Oct 11. doi: 10.1007/s00259-025-07569-5. Online ahead of print.

Reference Type DERIVED
PMID: 41074963 (View on PubMed)

Kreuzberger 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.

Reference Type DERIVED
PMID: 40135712 (View on PubMed)

van 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.

Reference Type DERIVED
PMID: 35717166 (View on PubMed)

Fuchs 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.

Reference Type DERIVED
PMID: 31498753 (View on PubMed)

Voltin 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.

Reference Type DERIVED
PMID: 30010775 (View on PubMed)

Narang 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.

Reference Type DERIVED
PMID: 25964643 (View on PubMed)

Related Links

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http://www.ghsg.org

Homepage GHSG

Other Identifiers

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HD16

Identifier Type: -

Identifier Source: org_study_id