NCT01596218

Brief Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD. Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease. Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease. In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

3.9 years

First QC Date

May 9, 2012

Last Update Submit

July 23, 2018

Conditions

Graft vs. Host Disease

Keywords

Steroid RefractoryAcute

Outcome Measures

Primary Outcomes (1)

  • Define MTD of Brentuximab Vedotin

    To define the maximum tolerated dose (MTD) of brentuximab vedotin when given as treatment for steroid-refractory acute GVHD

    2 years

Secondary Outcomes (6)

  • Overall Response Rate

    2 years

  • Identification of Toxicities

    2 years

  • Overall Survival

    2 years

  • Description of Cumulative Incidence of Chronic GVHD

    2 years

  • Assessment of Levels of Soluble CD30

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Treatment Arm for all participants - Brentuximab vedotin

Drug: Brentuximab Vedotin

Interventions

Brentuximab VedotinDRUG

Starting dose is 0.6 mg/kg weekly x 3

Also known as: SGN-35
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute GVHD
  • Corticosteroid refractory

You may not qualify if:

  • Pregnant or breastfeeding
  • Requiring mechanical ventilation
  • Concurrent hepatic VOD
  • Have received another study agent within 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yi-Bin Chen, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)