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Hodgkin LymphomaPhase 2NCT02247869

Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

A Phase 2 study testing dose dense ABVD in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 37 sites 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

Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
dose dense ABVD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
37 sitesItaly
Study dates
Feb 2012to 29 Apr 2017
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky.
  • Previously untreated
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2
  • Staging with FDG-PET (fluorodeoxyglucose positron emission tomography)
  • Written informed consent
  • Adequate liver and renal function (total serum bilirubin < 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN)

Who cannot join

  • Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease.
  • Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl)
  • Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years
  • Patients with a known history of HIV seropositivity
  • Active HCV infection (PCR + ; AST> 1.5-2x UN)
  • Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months.
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  • Negative pregnancy test at baseline is required (serum β HCG).
  • Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment
  • Nodular lymphocyte prevalence histological subtype

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Italy37 sites

  • UO Ematologia Ospedale San Donato

    Arezzo

  • Oncologia Medica A Centro di Riferimento Oncologico

    Aviano, Pordenone

  • UO Ematologia con trapianto AOU Policlinico Consorziale

    Bari

  • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi

    Biella

  • Ematologia e CTMO Ospedale Businco

    Cagliari

  • UOC Oncoematologia Garibaldi Nesima

    Catania

  • Oncologia HSR Giglio

    Cefalù, Palermo

  • UOC Ematologia Azienda Ospedaliera Cosenza

    Cosenza

  • Unità Funzionale di Ematologia AOU Careggi

    Florence

  • Ematologia- AOU San Martino IRCCS - IST

    Genova

  • SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4

    Ivrea

  • UO Ematologia PO Vito Fazzi

    Lecce

  • IRST Meldola

    Meldola

  • SC Ematologia AO Riuniti Papardo Piemonte

    Messina

  • UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo

    Milan

  • Centro Oncoematologico Policlinico

    Modena

  • Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli

    Naples

  • SCDU Ematologia Università Piemonte Orientale

    Novara

  • U.O. Oncoematologia Ospedale "Andrea Tortora"

    Pagani, Salerno

  • Oncoematologia e TMO Dopartimento Oncologia La Maddalena

    Palermo

  • UO Complessa di Ematologia Ospedale di Parma

    Parma

  • Clinica Ematologica Fondazione IRCCS Policlinico San Matteo

    Pavia

  • Ematologia Ospedale Santo Spirito

    Pescara

  • UO Ematologia Ospedale Santa Maria delle Croci

    Ravenna

  • SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova

    Reggio Emilia

  • UO Oncoematologia AUSL Rimini Ospedale Infermi

    Rimini

  • Ematologia e Trapianto Istituto Regina Elena IFO

    Roma

  • Ematologia Ospedale Sant'Andrea

    Roma

  • Ematologia Università La Sapienza

    Roma

  • Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas

    Rozzano, Milano

  • Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona

    Salerno

  • UO Ematologia Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia

  • Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte

    Siena

  • Oncoematologia Università Perugia sede Terni

    Terni

  • SC Ematologia AO Città della Salute e della Scienza

    Torino

  • Clinica Ematologica AO S. Maria della Misericordia

    Udine

  • UOC Ematologia Ospedale di Circolo

    Varese

Other trials in Italy

About this study

Official title: Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study

Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.

Read the detailed description

Dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas.

The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients, the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-ABVD activity.

Being tested
dose dense ABVD
Keywords
HL, Hodgkin Lymphoma, First line therapy
Medical subject headings
Hodgkin Disease

What participants receive

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

  • dose dense ABVDDrug

    dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen

    • Doxorubicin 25 mg/m2 i.v. day 1 and 8
    • Bleomycin 10 mg/m2 i.v. day 1 and 8
    • Vinblastine 6 mg/m2 i.v. day 1 and 8
    • Dacarbazine 375 mg/m2 i.v. day 1 and 8

    Granulocyte colony-stimulating factor (G-CSF): days 9 to 14

Study groups in NCT02247869
Study groupRoleWhat they receive
dose dense ABVDExperimental1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
Receives: Drug: dose dense ABVD

What is being measured

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

  1. Feasibility

    Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)

    Measured: After 4 dd-ABVD cycles (12 weeks after starting treatment)

  2. Activity

    Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.

    Measured: After 2 dd-ABVD cycles (6 week after starting treatment)

Secondary outcomes (5)

  1. Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years

    Concordance between pet results and patients prognosis

    Measured: After 3 years of follow-up

  2. PFS

    Progression free survival estimate (prognosis outcome)

    Measured: 2 years from the activation of therapy in the last patient enrolled onto the study.

  3. OS

    Overall survival estimate (prognosis outcome)

    Measured: 2 years from the activation of therapy in the last patient enrolled onto the study.

  4. Toxicity

    Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)

    Measured: 2 years from the activation of therapy in the last patient enrolled onto the study.

  5. Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years

    Concordance between pet results and patients prognosis

    Measured: After 3 years of follow-up

Timeline

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

  1. First posted25 Sep 2014 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2015
  4. Study completion29 Apr 2017

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247869
Sponsor's protocol ID
FIL - DDABVD
Status last verified
Feb 2018
First submitted
7 Mar 2014
Last updated
9 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Santoro A, Mazza R, Spina M, Califano C, Specchia G, Carella M, Consoli U, Palombi F, Musso M, Pulsoni A, Kovalchuk S, Bonfichi M, Ricci F, Fabbri A, Liberati AM, Rodari M, Giordano L, Chimienti E, Balzarotti M, Sorasio R, Gallamini A, Ghiggi C, Ciammella P, Ricardi U, Chauvie S, Carlo-Stella C, Merli F. Dose-dense ABVD as first-line therapy in early-stage unfavorable Hodgkin lymphoma: results of a prospective, multicenter double-step phase II study by Fondazione Italiana Linfomi. Ann Hematol. 2021 Oct;100(10):2547-2556. doi: 10.1007/s00277-021-04604-x. Epub 2021 Jul 30.

    PubMed 34327561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dose dense ABVD in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 37 sites 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 7 inclusion and 9 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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Feasibility (time frame: After 4 dd-ABVD cycles (12 weeks after starting treatment)). The study lists 2 primary outcomes in all. 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 NCT02247869, 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 9 Feb 2018.

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