NCT00136396

Brief Summary

The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

August 26, 2005

Last Update Submit

June 10, 2013

Conditions

Graft vs Host Disease

Keywords

Steroid-refractory Chronic Graft vs. Host DiseaseChronic Graft vs. Host DiseaseGVHDsteroid-refractoryrituximab

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD

    2 years

Secondary Outcomes (1)

  • To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD

    2 years

Interventions

RituximabDRUG

Given once weekly for 4 weeks followed by a 4 week observation therapy.

Eligibility Criteria

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

You may qualify if:

  • Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
  • At least 180 days since allogeneic stem cell transplantation procedure
  • Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
  • Stable dose of corticosteroids for 4 weeks prior to enrollment
  • Adequate bone marrow function: absolute neutrophil count (ANC) \> 500/mm; platelets \> 20,000 ul
  • Adequate renal function: creatinine \< 3.0 mg/dl
  • Adequate hepatic function: bilirubin \< 3.0 mg/dl; AST \< 90 IU

You may not qualify if:

  • Prednisone requirement greater than 2 mg/kg/day or equivalent
  • Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
  • Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
  • Active, uncontrolled infection
  • Evidence of natural exposure to hepatitis B or C.
  • Active malignant disease relapse
  • Donor lymphocyte infusion within the preceding 100 days.
  • Life expectancy of less than 3 months.
  • Pregnancy or lactation
  • Evidence of HIV seropositivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. doi: 10.1182/blood-2006-01-0233. Epub 2006 Mar 21.

    PMID: 16551963DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Corey S. Cutler, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

January 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2010

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

US(2)