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Hodgkin LymphomaPhase 2NCT02275598

Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma

A Phase 2 study testing Brentuximab vedotin and ABVD in people with Hodgkin Lymphoma, run by University of Modena and Reggio Emilia at 3 sites in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL). Read more about this study

Who is it for?
Ages 8 to 70 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Brentuximab vedotin and ABVD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesItaly
Study dates
Apr 2013to Mar 2015
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 8 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification
  • Histologically confirmed CD30+ HL
  • Stage IA, IIA, IIIA
  • Absence of bulky disease
  • FDG-PET at baseline
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Show all 13Show fewer
  • Life expectancy > 6 months.
  • Age 18-70 years.
  • Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
  • Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy).
  • Written informed consent.
  • Required baseline laboratory data:
  • Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Who cannot join

  • Peripheral neuropathy > Grade 1
  • Histologic diagnosis different from Hodgkin Lymphoma
  • Compressive symptoms
  • Patients previously treated with any anti-CD30 antibody
  • Known human immunodeficiency virus (HIV) positive
  • Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C
  • Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML)
  • Patients with known cerebral/meningeal disease.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna

    Bologna, 40138

  • Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia

    Modena, 41124

  • Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS

    Reggio Emilia, 42100

Other trials in Italy

About this study

Official title: A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.

The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).

Read the detailed description

This is a multicenter pilot phase II trial assessing 2 administrations of Brentuximab vedotin followed by PET scan and subsequent standard treatment with ABVD ± Radiotherapy. 12 patients defined by inclusion and exclusion criteria will be enrolled in one year. All subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study. For all study procedures patient will be assigned a Unique Subject Identifier (SID) number that will be used to identify the subject during the screening process and throughout study participation. A master log will be maintained of all consented subjects and will document all screening failures (i.e. subjects who are consented but do not meet study eligibility criteria). Study records such as case report forms (CRFs) may be maintained electronically and require the same security and confidentiality as paper. Clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form

Being tested
Brentuximab vedotin, ABVD
Medical subject headings
Hodgkin Disease

What participants receive

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

  • Brentuximab vedotinDrug

    Also called Adcetris

    1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2

  • ABVDDrug

    Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.

Study groups in NCT02275598
Study groupRoleWhat they receive
BV-ABVDExperimentalTreatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
Receives: Drug: Brentuximab vedotin; Drug: ABVD

What is being measured

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

  1. Number of Participants with Complete Metabolic Response by FDG-PET

    Complete Metabolic Response will be defined by Deauville score 1, 2, 3.

    Measured: between day +8 and day +15 from second administration of Brentuximab

Secondary outcomes (3)

  1. Overall Response Rate (ORR)

    Measured: Up to 4 weeks from the end of full treatment program.

  2. Progression Free Survival (PFS)

    Measured: at 1 year from the end of full treatment program.

  3. Number of Participants with Adverse Events

    All serious and on-serious adverse events will be assessed

    Measured: from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.

Timeline

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

  1. First posted27 Oct 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionMar 2015 (estimated)

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275598
Sponsor's protocol ID
BV-ABVD
Status last verified
Oct 2014
First submitted
8 Oct 2014
Last updated
27 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab vedotin and ABVD in people with Hodgkin Lymphoma, run by University of Modena and Reggio Emilia at 3 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

Number of Participants with Complete Metabolic Response by FDG-PET (time frame: between day +8 and day +15 from second administration of Brentuximab). 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 NCT02275598.

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 27 Oct 2014.

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