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LymphomaPhase 3H10NCT00433433

Fludeoxyglucose F 18 PET Scan-Guided Therapy or Standard Therapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

A Phase 3 study testing ABVD q4 weeks, BEACOPP escalated q3 weeks and IN-RT 30 Gy (+ boost 6 Gy residual) in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study

Who is it for?
Ages 15 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
ABVD q4 weeks, BEACOPP escalated q3 weeks and IN-RT 30 Gy (+ boost 6 Gy residual)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,952 participants
Where
1 siteNetherlands
Study dates
Oct 2006to Dec 2011
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 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma
  • No nodular lymphocyte-predominant subtype (nodular paragranuloma)
  • Supradiaphragmatic Ann Arbor clinical stage I or II disease
  • Must meet criteria for 1 of the following prognostic subsets:
  • Unfavorable subset, defined as meeting 1 of the following criteria:
  • Clinical stage II disease with ≥ 4 nodal areas involved
  • Mediastinum and hili are considered as 1 nodal area
  • Age ≥ 50 years
  • Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms
  • ESR ≥ 30 mm/hr with B symptoms
  • Mediastinum/thoracic (MT) ratio ≥ 0.35
  • Favorable subset, defined as meeting all of the following criteria:
  • Clinical stage I disease OR stage II disease with ≤ 3 involved areas
  • Age < 50 years
  • ESR < 50 mm/hr (no B symptoms) OR ESR < 30 mm/hr (B symptoms present)
  • MT ratio < 0.35
  • Previously untreated disease
  • Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-3
  • Bilirubin ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease
  • No unstable diabetes mellitus
  • No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix
  • No known HIV infection
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • Not specified

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

Other trials in Netherlands

About this study

Official title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in terms of progression-free survival (PFS), in patients with favorable or unfavorable supradiaphragmatic stage I or II Hodgkin's lymphoma who are fludeoxglucose F 18 positron emission tomography (FDG-PET) scan negative after two courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).

Secondary

  • Evaluate whether early change of chemotherapy from ABVD to escalated cyclophosphamide, doxorubicin hydrochloride, vincristine, bleomycin, etoposide, procarbazine hydrochloride, and prednisone (escalated BEACOPP) improves the PFS of patients who are FDG-PET scan positive after two courses of ABVD.
  • Confirm that early response by FDG-PET scan is predictive of the outcome of patients randomized to the standard treatment arm.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease prognostic profile (favorable vs unfavorable), participating center, Ann Arbor clinical stage (I vs II), and availability of a baseline fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard [closed to accrual as of 6/24/2011]): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV or intramuscularly (IM), vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with favorable prognostic profile receive 3 courses of ABVD. Patients with unfavorable prognostic profile receive 4 courses of ABVD. Patients undergo FDG-PET scan after completion of 2 courses of ABVD. Beginning 3-4 weeks after completion of ABVD, patients undergo involved-node radiotherapy (INRT) 5 days a week for 4-6 weeks.
  • Arm II (experimental): Patients receive ABVD as in arm I for 2 courses and then undergo FDG-PET scan. Further treatment is adapted according to FDG-PET scan result.
  • FDG-PET negative: Patients with favorable prognostic profile receive 1 additional courses of ABVD. Patients with unfavorable prognostic profile receive 2 additional courses of ABVD. Patients with favorable or unfavorable prognostic profiles randomized on or after August 9th 2010 who are FDG-PET negative after two courses of ABVD will receive standard combined modality treatment consisting of ABVD and INRT as in arm I.
  • FDG-PET positive: Patients receive ABVD as in arm I for 2 courses or intensification to escalated BEACOPP chemotherapy comprising cyclophosphamide IV and doxorubicin hydrochloride IV on day 1, vincristine IV and bleomycin IV or IM on day 8, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and filgrastim (G-CSF) subcutaneously beginning on day 9 and continuing until blood count recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of ABVD or BEACOPP, patients undergo INRT 5 days a week for 4-6 weeks.

After completion of study treatment, patients are followed periodically for at least 10 years.

PROJECTED ACCRUAL: A total of 1,797 patients will be accrued for this study.

Conditions
Lymphoma
Being tested
ABVD q4 weeks, BEACOPP escalated q3 weeks, IN-RT 30 Gy (+ boost 6 Gy residual), FDG-PET scan
Keywords
adult mixed cellularity Hodgkin lymphoma, adult nodular sclerosis Hodgkin lymphoma, stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, adult lymphocyte depletion Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

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

  • ABVD q4 weeksDrug

    Doxorubicin 25 mg/m2 i.v. day 1 and 15; Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15; Vinblastine 6 mg/m2 i.v. day 1 and 15; Dacarbazine 375 mg/m2 i.v. day 1 and 15

  • BEACOPP escalated q3 weeksDrug

    Cyclophosphamide 1250 mg/m2 i.v. day 1; Doxorubicin 35 mg/m2 i.v. day 1; Vincristine 1.4 mg/m2 i.v.(max.2mg) day 8; Bleomycin 10 mg/m2 i.v./i.m. day 8; Etoposide 200 mg/m2/ i.v. day 1 to 3; Procarbazine 100 mg/m2 orally day 1 to 7; Prednisone 40 mg/m2 orally day 1 to 14; G-CSF 5 mcg/kg s.c. day 9 to recovery leukocytes>1.0x109/l

  • IN-RT 30 Gy (+ boost 6 Gy residual)Radiation

    Also called Involved-Note Radiation Therapy

  • FDG-PET scanProcedure or surgery

    Also called F-18 fluorodeoxyglucose positron emission tomography scan

Study groups in NCT00433433
Study groupRoleWhat they receive
Favorable - Standard - any PET outcomeActive comparatorABVDx3 cycles + Involved node RT (IN-RT) 30 Gy (+boost of 6Gy to residual lesions); FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
Receives: Drug: ABVD q4 weeks; Radiation: IN-RT 30 Gy (+ boost 6 Gy residual); Procedure: FDG-PET scan
Favorable - Experimental - PET negativeExperimentalABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx2 without further RT (total of 4 cycles!)
Receives: Drug: ABVD q4 weeks; Procedure: FDG-PET scan
Favorable - Experimental - PET positiveExperimentalABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions).
Receives: Drug: BEACOPP escalated q3 weeks; Radiation: IN-RT 30 Gy (+ boost 6 Gy residual); Procedure: FDG-PET scan
Unfavorable - Standard - Any PET outcomeActive comparatorABVDx4 cycles + IN-RT 30Gy (+boost 6Gy to residual lesions). FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place.
Receives: Drug: ABVD q4 weeks; Radiation: IN-RT 30 Gy (+ boost 6 Gy residual); Procedure: FDG-PET scan
Unfavorable - Experimental - PET negativeExperimentalABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx 4 cycles, without RT (total of 6 cycles)
Receives: Drug: ABVD q4 weeks; Procedure: FDG-PET scan
Unfavorable - Experimental - PET positiveExperimentalABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions).
Receives: Drug: BEACOPP escalated q3 weeks; Radiation: IN-RT 30 Gy (+ boost 6 Gy residual); Procedure: FDG-PET scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (3)

  1. Event-free survival

  2. Overall survival

  3. Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events

Timeline

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

  1. First posted12 Feb 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2011

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
Parallel groups
Masking
None (open label)
Enrolment
1,952 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433433
Sponsor's protocol ID
EORTC-20051
Other IDs
EORTC-20051, GELA-H10, IIL-EORTC-20051, EUDRACT-2005-002765-37, EU-20657
Acronym
H10
Status last verified
Feb 2021
First submitted
8 Feb 2007
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • André M, Reman O, Fédérico M, et al.: First report on the H10 EORTC/GELA/IIL randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supra-diaphragmatic stage I/II Hodgkin's lymphoma, for the Groupe d'Etude Des Lymphomes De l'Adulte (GELA), European Organisation for the Research and Treatment of Cancer (EORTC) Lymphoma Group and the Intergruppo Italiano Linfomi (IIL) . [Abstract] Blood 114 (22): A-97, 2009.

  • 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.

    PubMed 40135712

  • Phillips EH, Counsell N, Illidge T, Andre M, Aurer I, Fiaccadori V, Fortpied C, Neven A, Federico M, Barrington SF, Raemaekers J, Radford J. Maximum tumor diameter is associated with relapse risk in limited-stage Hodgkin lymphoma: an international study. Blood Adv. 2025 May 13;9(9):2266-2274. doi: 10.1182/bloodadvances.2024015140.

    PubMed 39774828

  • Fiaccadori V, Neven A, Fortpied C, Aurer I, Andre M, Federico M, Counsell N, Phillips EH, Clifton-Hadley L, Barrington SF, Illidge T, Radford J, Raemaekers JMM. Relapse patterns in early-PET negative, limited-stage Hodgkin lymphoma (HL) after ABVD with or without radiotherapy-a joint analysis of EORTC/LYSA/FIL H10 and NCRI RAPID trials. Br J Haematol. 2023 Mar;200(6):731-739. doi: 10.1111/bjh.18594. Epub 2022 Dec 21.

    PubMed 36541117

  • Cottereau AS, Versari A, Loft A, Casasnovas O, Bellei M, Ricci R, Bardet S, Castagnoli A, Brice P, Raemaekers J, Deau B, Fortpied C, Raveloarivahy T, Van Zele E, Chartier L, Vander Borght T, Federico M, Hutchings M, Ricardi U, Andre M, Meignan M. Prognostic value of baseline metabolic tumor volume in early-stage Hodgkin lymphoma in the standard arm of the H10 trial. Blood. 2018 Mar 29;131(13):1456-1463. doi: 10.1182/blood-2017-07-795476. Epub 2018 Feb 1.

    PubMed 29437590

  • Raemaekers JM, Andre MP, Federico M, Girinsky T, Oumedaly R, Brusamolino E, Brice P, Ferme C, van der Maazen R, Gotti M, Bouabdallah R, Sebban CJ, Lievens Y, Re A, Stamatoullas A, Morschhauser F, Lugtenburg PJ, Abruzzese E, Olivier P, Casasnovas RO, van Imhoff G, Raveloarivahy T, Bellei M, van der Borght T, Bardet S, Versari A, Hutchings M, Meignan M, Fortpied C. Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse: Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2014 Apr 20;32(12):1188-94. doi: 10.1200/JCO.2013.51.9298. Epub 2014 Mar 17.

    PubMed 24637998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABVD q4 weeks, BEACOPP escalated q3 weeks and IN-RT 30 Gy (+ boost 6 Gy residual) in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 3 Feb 2021. 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 Netherlands. 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. 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 NCT00433433, 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 3 Feb 2021.

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