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Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

10. juni 2013 opdateret af: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease

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).

Studieoversigt

Status

Afsluttet

Betingelser

Graft vs værtssygdom

Intervention / Behandling

Medicin: Rituximab

Detaljeret beskrivelse

Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.

At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.

If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.

If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.

If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.

Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, Forenede Stater, 02115
    - Brigham and Women's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD Tidsramme: 2 years	2 years

Sekundære resultatmål

Resultatmål	Tidsramme
To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD Tidsramme: 2 years	2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dana-Farber Cancer Institute

Samarbejdspartnere

Brigham and Women's Hospital

Efterforskere

Ledende efterforsker: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2004

Primær færdiggørelse (Faktiske)

1. november 2006

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

26. august 2005

Først indsendt, der opfyldte QC-kriterier