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

Sponsor

University of Modena and Reggio Emilia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02275598

Collaborator

Millennium Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: Brentuximab vedotin Drug: ABVD	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BV-ABVD Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).	Drug: Brentuximab vedotin 1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2 Other Names: Adcetris Drug: ABVD 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.

Arm

Intervention/Treatment

Experimental: BV-ABVD

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

Drug: Brentuximab vedotin

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

Other Names:

Adcetris

Drug: ABVD

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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Complete Metabolic Response by FDG-PET [between day +8 and day +15 from second administration of Brentuximab]
Complete Metabolic Response will be defined by Deauville score 1, 2, 3.

Secondary Outcome Measures

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.]
All serious and on-serious adverse events will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna	Bologna	Italy	40138
2	Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia	Modena	Italy	41124
3	Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS	Reggio Emilia	Italy	42100

Sponsors and Collaborators

University of Modena and Reggio Emilia
Millennium Pharmaceuticals, Inc.

Investigators

Study Chair: Massimo Federico, MD, Department of Diagnostic, Clinical and Public Health Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Massimo Federico, MD, Full Professor, University of Modena and Reggio Emilia

ClinicalTrials.gov Identifier:

NCT02275598

Other Study ID Numbers:

BV-ABVD

First Posted:

Oct 27, 2014

Last Update Posted:

Oct 27, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Brentuximab Vedotin

Study Results

No Results Posted as of Oct 27, 2014