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Hodgkin´s LymphomaPhase 3NCT00264953

HD11 for Intermediate Stages

A Phase 3 study testing Adriamycin, Bleomycin and Vinblastine in people with Hodgkin´s Lymphoma, run by University of Cologne.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Hodgkin´s Lymphoma
What is being tested?
Adriamycin, Bleomycin and Vinblastine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,395 participants
Where
No sites listed yet
Study dates
May 1998to Jan 2003
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 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Hodgkin´s lymphoma (histologically proven)
  • CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d
  • bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
  • extranodal involvement
  • ESR > 50 (A), > 30 (B-symptoms)
  • 3 or more lymph node areas involved
  • written informaed consent

Who cannot join

  • Leukocytes <3000/microl
  • Platelets <100000/microl
  • Hodgkin´s Disease as "composite lymphoma"
  • Activity index (WHO) < grade 2

About this study

This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.

Being tested
Adriamycin, Bleomycin, Vinblastine, DTIC, Etoposide
Keywords
Hodgkin´s lymphoma, intermediate stages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdriamycinDrug

  • BleomycinDrug

  • VinblastineDrug

  • DTICDrug

  • EtoposideDrug

  • ProcarbazineDrug

  • PrednisoneDrug

  • VincristineDrug

  • radiation therapyRadiation

    20 or 30Gy IF-RT

Study groups in NCT00264953
Study groupRoleWhat they receive
AActive comparator4x ABVD plus 30Gy IF-RT
Receives: Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: radiation therapy
CExperimental4x BEACOPP baseline plus 30Gy IF-RT
Receives: Drug: Adriamycin; Drug: Bleomycin; Drug: Etoposide; Drug: Procarbazine; Drug: Prednisone; Drug: Vincristine; Radiation: radiation therapy
BExperimental4x ABVD plus 20Gy IF-RT
Receives: Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: DTIC; Radiation: radiation therapy
DExperimental4x BEACOPP baseline plus 20Gy IF-RT
Receives: Drug: Adriamycin; Drug: Bleomycin; Drug: Etoposide; Drug: Procarbazine; Drug: Prednisone; Drug: Vincristine; Radiation: radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2005 (estimated)
  2. Study startMay 1998
  3. Primary completionJan 2003

Resources

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
Factorial
Masking
None (open label)
Enrolment
1,395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264953
Sponsor's protocol ID
HD11
Status last verified
Jul 2011
First submitted
12 Dec 2005
Last updated
4 Aug 2011
Results posted
No

Publications

  • Eich HT, Diehl V, Gorgen H, Pabst T, Markova J, Debus J, Ho A, Dorken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Dohner H, Borchmann P, Muller-Hermelink HK, Muller RP, Engert A. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010 Sep 20;28(27):4199-206. doi: 10.1200/JCO.2010.29.8018. Epub 2010 Aug 16.

    PubMed 20713848

  • Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.

    PubMed 24121121

  • Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.

    PubMed 23509310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adriamycin, Bleomycin and Vinblastine in people with Hodgkin´s Lymphoma, run by University of Cologne.

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: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00264953, which also lists 3 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 Aug 2011.

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