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Hodgkin LymphomaPhase 3NCT01251107

Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

A Phase 3 study testing Bleomycin, Etoposide and Doxorubicin in people with Hodgkin Lymphoma, run by Fondazione Michelangelo at 1 site in Italy.

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

The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy… Read more about this study

Who is it for?
Ages 17 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Bleomycin, Etoposide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
1 siteItaly
Study dates
Mar 2000to Nov 2009
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 17 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological review diagnosis available)
  • No prior treatment
  • Stage II B, III A and B, IV A and B
  • Normal hematopoietic function as measured by leucocytes equal to or greater than 3500/mm3, neutrophils equal to or greater than 1500/mm3, platelets equal to or greater than 100000/mm3
  • Normal renal function (serum creatinine < 1,5x ULN) and normal liver function (SGOT/SGPT equal to or lower than 2.5x ULN; bilirubin equal to or lower than 1.5x ULN)
  • No significant history or current evidence of cardiovascular disease, or major respiratory disease
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  • No severe neurologic or psychiatric disease
  • No other malignancy except basal cell carcinoma of the skin and/or in situ cervical carcinoma of the uterus
  • Serological negativity for hepatitis B or C or HIV infection
  • ECOG performance status equal to or lower than 2
  • Life expectancy of at least three months
  • Effective contraception in all patients and a negative pregnancy test for women of childbearing potential
  • Written informed consent and consent to a regular follow-up in the outpatient clinic

Who cannot join

  • Sever central nervous system or psychiatric disease
  • History or current evidence of clinically significant cardiac disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease or myocardial infarction or severe arrhythmias. Left ventricular ejection fraction < 50% at rest by echocardiography or < 55% by isotopic measurement
  • Serological positivity for HBV, HCV or HIV
  • History or current evidence of malignancy other than basal cell carcinoma of the skin, carcinoma in situ of the cervix
  • Lactating or pregnant women

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale di Tumori di Milano

    Milan

Other trials in Italy

About this study

Official title: Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)

The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.

Read the detailed description

During the last two decades ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) has been considered as the standard of care for advanced HL, however 20-30% of the patients fail to achieve a durable complete remission and need a salvage treatment. After a state-of-the art-salvage program including high-dose chemotherapy and autologous hematopoietic stem cell support (ASCT) at least half of these patients achieve a durable disease control. Recently the German Hodgkin Study Group (GHSG) has developed a new regimen, BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone), administered with or without dose escalation. In an interim analysis after 23 months follow-up, BEACOPP demonstrated a higher activity compared to COPP/ABVD with a superior freedom from treatment failure (84% versus 75%, P=.034). Despite the improved efficacy a substantial proportion of patients receiving escalated BEACOPP experienced severe acute hematologic toxicity (grade 3-4 leucopoenia, thrombocytopenia and anemia occurred in 78% , 36% and 27% of the cycles administered, respectively) and 1.8% fatal acute toxicities were reported. Moreover of greater concern is the incidence of almost fatal secondary acute leukemia and myelodysplastic syndrome (3 cases in 323 patients). The choice of first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related toxicities. Long-term outcome following an optimal salvage treatment, consisting in high-dose chemotherapy with ASCT should also be taken into consideration. In the present study we plan to compare the efficacy and toxicity of two therapeutic strategies consisting in two different first-line treatments followed by a pre-planned salvage program, when indicated

Keywords
Hodgkin lymphoma, ABVD, BEACOPP, Salvage high dose chemotherapy
Medical subject headings
Hodgkin Disease

What participants receive

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

  • BleomycinDrug

    Also called Bleomicina Teva

    10 mg/m2 IV day 8 during cycles 1 to 8

  • EtoposideDrug

    Also called VP-16, Etoposide Teva

    200 mg/m2 iv on days 1 to 3 during cycles 1 to 4; 100 mg/m2 iv on days 1 to 3 during cycles 5 to 8

  • DoxorubicinDrug

    Also called Adriblastina Pfizer

    35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8

  • CyclophosphamideDrug

    Also called Endoxan Baxter

    1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8

  • VincristineDrug

    Also called Vincristina Teva Italia

    1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8

  • ProcarbazineDrug

    Also called Natulan

    100 mg/m2 po from day 1 to 7 during cycles 1 to 8

  • PrednisoneDrug

    Also called Deltacortene

    40 mg/m2 po from day 1 to 14 during cycles 1 to 8

  • DoxorubicinDrug

    Also called Adriblastina Pfizer

    25 mg/m2 iv on days 1 and 15 in each cycle

  • BleomycinDrug

    Also called Bleomicina Teva

    10 mg/m2 iv on days 1 and 15 in each cycle

  • VinblastineDrug

    Also called Velbe

    6 mg/m2 iv on days 1 and 15 in each cycle

  • DacarbazineDrug

    Also called Dacarbazina Medac

    375 mg/m2 iv on days 1 and 15 in each cycle

Study groups in NCT01251107
Study groupRoleWhat they receive
Arm BExperimentalBEACOPP (Bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) for 4 escalated cycles followed by 4 standard cycles
Receives: Drug: Bleomycin; Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone
Arm AActive comparatorABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 6 to 8 cycles
Receives: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine

What is being measured

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

  1. Freedom from first progression at 5 years

    Measured: After a median of 5 years from start of the study

Secondary outcomes (4)

  1. Freedom from second progression at 5 years

    Measured: After a median of 5 years from start of protocol

  2. Overall survival at 5 years

    Measured: After a median of 5 years from start of the protocol

  3. Number of participants with acute adverse events at initial therapy and at salvage therapy as a measure of safety and tolerability

    Measured: After 3 months from last intervention

  4. Number of participants long term sequelae

    Number of participants who developed leukemia Number of participants who developed solid tumors Number of participants who developed cardiovascular disease

    Measured: After a median of 10 years

Timeline

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

  1. First posted1 Dec 2010 (estimated)
  2. Study startMar 2000
  3. Primary completionNov 2009
  4. Study completionNov 2009

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
Single group
Masking
None (open label)
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251107
Sponsor's protocol ID
41/99
Status last verified
Feb 2011
First submitted
26 Nov 2010
Last updated
13 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Viviani S, Zinzani PL, Rambaldi A, Brusamolino E, Levis A, Bonfante V, Vitolo U, Pulsoni A, Liberati AM, Specchia G, Valagussa P, Rossi A, Zaja F, Pogliani EM, Pregno P, Gotti M, Gallamini A, Rota Scalabrini D, Bonadonna G, Gianni AM; Michelangelo Foundation; Gruppo Italiano di Terapie Innovative nei Linfomi; Intergruppo Italiano Linfomi. ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned. N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340.

    PubMed 21774708

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bleomycin, Etoposide and Doxorubicin in people with Hodgkin Lymphoma, run by Fondazione Michelangelo at 1 site in Italy.

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 13 inclusion and 5 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 13 Aug 2015. 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 Italy. 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?

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.

What does the primary outcome measure?

Freedom from first progression at 5 years (time frame: After a median of 5 years from start of the study). 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 NCT01251107, which also lists 1 linked publication.

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 13 Aug 2015; AzTrials last refreshed its copy on 1 Nov 2026.

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