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Hodgkin LymphomaPhase 2HD0803NCT01523847

A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

A Phase 2 study testing MBVD (Myocet+BVD) in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 26 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

The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
MBVD (Myocet+BVD)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
26 sitesItaly
Study dates
Nov 2010to Oct 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed Hodgkin's lymphoma, except for nodular lymphocyte predominance subgroup.
  • Previously untreated
  • Age ≥ 70.
  • Age> 18 in presence of cardiopathy according to inclusion criteria…
  • Patients with HCV and HBV infection can be included. For patients HBV+ occult carriers (AntiHBc+, HbsAg-, AntiHBs+/-) Lamivudine prophylaxis is mandatory.
  • Life expectancy >3 months
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  • Informed consent.
  • Staging with PET-CT.
  • Preliminary geriatric assessment (ADL, IADL, co-morbidity and frailness scores).

Who cannot join

  • Lymphocyte predominance subgroup
  • Age < 70 (no cardiopathy)
  • Age < 18 (with cardiopathy).
  • HIV infection.
  • Previous treatments for Hodgkin's lymphoma.
  • Other concomitant or previous malignancies, with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for > 5 years.
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  • Renal failure (creatinine higher than twice the normal level) or liver disease (AST/ALT or bilirubin level higher than 2.5 times the normal level)
  • Other clinical situations that contraindicate, to the judgment of investigators, the administration of a mild-dose chemotherapy. Isolated comorbidities will be scored and recorded, but they are not, if isolated, a sufficient reason for exclusion.
  • Frail patients, defined according to comorbidity scale: patients with 1 grade 4 comorbidity, or >3 grade 3 comorbidities, are excluded. (see appendix.6)
  • Unresponsive sepsis
  • Dementia
  • Impossibility to subscribe the informed consent

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Italy26 sites

  • Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

    Alessandria, Alessandria, 15121

  • Centro di riferimento Oncologico

    Aviano

  • IRCC Istituto Tumori

    Bari

  • Policlinico S. Orsola Malpighi

    Bologna

  • Spedali Civili

    Brescia

  • Ospedale "A. Perrino"

    Brindisi, Brindisi, 72100

  • Ospedale Businco

    Cagliari

  • A.S.U.R. Zona Territoriale n°8 - Ospedale di Civitanova Marche U.O. Medicina Interna ed Ematologia

    Civitanova Marche, Macerata, 62012

  • SC Medicina trasfusionale ed Ematologia Ospedale civile di Ivrea

    Ivrea, Torino, 10015

  • Ematologia Ospedale Vito Fazzi

    Lecce, Lecce, 73100

  • Area Vasta Romagna e IRST

    Meldola (FC)

  • Ospedale Maggiore della Carità

    Novara

  • Azienda Ospedaliera V.Cervello

    Palermo, Palermo, 90146

  • Fondazione Policlinico San Matteo

    Pavia

  • Ospedale Guglielmo da Saliceto

    Piacenza, Piacenza, 29100

  • Osp. S. Maria delle Croci

    Ravenna

  • Azienda Ospedaliera "Bianchi Melacrino Morelli"

    Reggio Calabria, Reggio Calabria, 89124

  • Ematologia Azienda Ospedaliera Arcispedale "S. Maria Nuova"

    Reggio Emilia, Reggio Emilia, 42100

  • Divisione di Oncologia Ospedale civile degli Infermi

    Rimini, Rimini, 47900

  • U.O.C. Ematologia IRCCS Istituti Fisioterapici Ospitalieri

    Roma, Roma, 00144

  • Ospedale S. Eugenio

    Roma

  • Università "La Sapienza"

    Roma

  • Ospedale Santa Maria

    Terni

  • Struttura Complessa di Ematologia PO TREVISO

    Treviso, Treviso, 31100

  • Ospedale Cardinale Giovanni Panico

    Tricase, Lecce, 73039

  • Azienda Ospedaliero - Universitaria di Udine

    Udine

Other trials in Italy

About this study

Official title: A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen.

Read the detailed description

STUDY POPULATION Patients affected by Hodgkin's lymphoma, any stage, older than 69 years. Patients affected by Hodgkin's Lymphoma with concomitant cardiopaty, older than 18 years.

AIMS OF THE STUDY

  • To evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen
  • To compare in a pair-match retrospective analysis the results obtained with MBVD with those obtained in patients comparable for clinical variables and treated with ABVD or with the reduced intensity VEPEMB schedule.

STUDY DESIGN Multi-centre phase II study SAMPLE SIZE 50 patients

STUDY PROCEDURES

  • Histologic diagnosis of Hodgkin Lymphoma.
  • Early Staging evaluation including:
  • Blood tests
  • CT, PET and bone marrow biopsy.
  • Heart and lung function evaluation.
  • Geriatric assessment.
  • Quality of life evaluation.
  • 2 MBVD courses
  • Early restaging with PET scan (PET-2)
  • The subsequent treatment will be planned as follows:
  • Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36Gy).
  • Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30-36 Gy) is optional.
  • Final restaging including:
  • Blood tests
  • CT, PET
  • bone marrow biopsy if positive at baseline.
  • Heart and lung function evaluation.
  • Geriatric assessment.
  • Quality of life evaluation

Follow up procedures will include:

  1. a clinical and laboratory evaluation (with troponin, proBNP / BNP, cardiology visit, ECG and echocardiogram) every 6 months in the first 2 years, then annually.
  2. CT scans will be planned annually.
  3. Compilation of geriatric evaluation scales every 6 months in the first 2 years, then annually.

MBVD will be scheduled as follows (4 weeks):

Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15 Supportive treatment with G-CSF and/or Erythropoietin will be planned according to international guide-lines.

Being tested
MBVD (Myocet+BVD)
Keywords
Hodgkin Lymphoma, Cardiopathic, elderly, Myocet
Medical subject headings
Hodgkin Disease

What participants receive

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

  • MBVD (Myocet+BVD)Drug

    Also called MBVD

    MBVD will be scheduled as follows:

    Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15

Study groups in NCT01523847
Study groupRoleWhat they receive
MBVD (Myocet+BVD)Experimental2 MBVD courses, after early restaging with PET scan (PET-2) The subsequent treatment will be planned as follows: * -Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36 Gy). * -Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30 Gy) is optional.
Receives: Drug: MBVD (Myocet+BVD)

What is being measured

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

  1. Complete Response (CR) at the end of the chemotherapy program

    CR is defined according to the Cheson 2007 response criteria.

    Measured: 24 weeks

  2. Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3

    Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3

    Measured: 24 weeks

Secondary outcomes (6)

  1. Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3

    Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.

    Measured: 8 weeks

  2. Progression Free Survival (PFS)

    PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause

    Measured: 24 months

  3. Relapse Free Survival (RFS) of patients entering complete remission

    RFS is defined only for patients who achieve CR, and is measured from the date of attaining the disease-free state until the date of relapse or death from any cause

    Measured: 24 months

  4. Overall Survival (OS)

    OS will be measured from the day of enrolment to the date of relapse or death due to any cause

    Measured: 24 months

  5. Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity)

    Proportion of dose-intensity delivered to patients

    Measured: 24 weeks

  6. Change in cardiac markers during and at the end of chemotherapy

    Evaluate Change in cardiac markers during and at the end of chemotherapy

    Measured: 24 weeks

Timeline

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

  1. First posted1 Feb 2012 (estimated)
  2. Study startNov 2010
  3. Primary completionOct 2013
  4. Study completionOct 2013

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01523847
Sponsor's protocol ID
IIL - HD0803
Other IDs
EudraCT Number 2009-013839-37
Acronym
HD0803
Status last verified
Aug 2016
First submitted
22 Jun 2011
Last updated
4 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MBVD (Myocet+BVD) in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 26 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 9 inclusion and 12 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 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

Complete Response (CR) at the end of the chemotherapy program (time frame: 24 weeks). 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 NCT01523847.

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 2016.

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