NCT02275598

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

October 8, 2014

Last Update Submit

October 22, 2014

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Complete Metabolic Response by FDG-PET

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

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

Secondary Outcomes (3)

  • Overall Response Rate (ORR)

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

  • Progression Free Survival (PFS)

    at 1 year from the end of full treatment program.

  • Number of Participants with Adverse Events

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

Study Arms (1)

BV-ABVD

EXPERIMENTAL

Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).

Drug: Brentuximab vedotinDrug: ABVD

Interventions

Brentuximab vedotinDRUG

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

Also known as: Adcetris
BV-ABVD
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.

BV-ABVD

Eligibility Criteria

Age8 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Bologna, 40138, Italy

Location

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

Modena, 41124, Italy

Location

Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS

Reggio Emilia, 42100, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Massimo Federico, MD

    Department of Diagnostic, Clinical and Public Health Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 27, 2014

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2015

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

IT(3)