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

Primary Purpose

Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Brentuximab vedotin
ABVD
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma

Eligibility Criteria

8 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
  • Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
  • Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BV-ABVD

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Complete Metabolic Response by FDG-PET
Complete Metabolic Response will be defined by Deauville score 1, 2, 3.

Secondary Outcome Measures

Overall Response Rate (ORR)
Progression Free Survival (PFS)
Number of Participants with Adverse Events
All serious and on-serious adverse events will be assessed

Full Information

First Posted
October 8, 2014
Last Updated
October 22, 2014
Sponsor
University of Modena and Reggio Emilia
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02275598
Brief Title
Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BV-ABVD
Arm Type
Experimental
Arm Description
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
Intervention Type
Drug
Intervention Name(s)
Brentuximab vedotin
Other Intervention Name(s)
Adcetris
Intervention Description
1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2
Intervention Type
Drug
Intervention Name(s)
ABVD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Complete Metabolic Response by FDG-PET
Description
Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
Time Frame
between day +8 and day +15 from second administration of Brentuximab
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
Up to 4 weeks from the end of full treatment program.
Title
Progression Free Survival (PFS)
Time Frame
at 1 year from the end of full treatment program.
Title
Number of Participants with Adverse Events
Description
All serious and on-serious adverse events will be assessed
Time Frame
from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Federico, MD
Organizational Affiliation
Department of Diagnostic, Clinical and Public Health Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy

12. IPD Sharing Statement

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

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