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ANTI-CD20 THERAPY FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE


- candidate number3045
- NTR NumberNTR1222
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2008
- Secondary IDs2006-3685 KWF
- Public TitleANTI-CD20 THERAPY FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE
- Scientific TitleANTI-CD20 THERAPY FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE
- ACRONYMN/A
- hypothesisAnti CD20 therapy will result in complete or partial response in patients with chronic GVHD, who do not respond to first line treatment.
- Healt Condition(s) or Problem(s) studiedAllogeneic stem cell transplantation, B-cell depletion, Chronic graft-versus-host disease
- Inclusion criteria1. Age > = 18 years
2. Chronic GVHD, including skin localization, refractory or dependent to first line treatment consisting of steroids and/or ciclosporine. Refractory cGVHD is defined as progressive cGVHD after at least 2 weeks of first line treatment or no response after 4 weeks of first line treatment.. Dependent cGVHD is defined as an inability to taper immunosuppressive treatment.
3. Written informed consent
4. WHO performance status 2
- Exclusion criteria1. Relapse and a life expectancy of < 6 months
2. Life expectancy of < 6 months
3. Systemic infections: active viral infections, including HIV
4. Other treatment for GVHD apart from steroids, ciclosporine and, when applicable, standard GVHD prevention
5. Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value
6. Neutrophil count <1.5 x 109/l and hemoglobin level <6.2 mmol/l
7. Pregnant or lactating
8. Any experimental therapy within 30 days prior to randomization
9. Known sensitivity or allergy to murine products
10. Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-nov-2010
- Target number of participants30
- InterventionsTreatment with rituximab (anti-CD20 monoclonal antibody) 375 mg/m2 i.v. for four weeks (weekly)
Monthly clinical report and physical examination
3 x skin biopsy
3 x Shirmer test
7 x 40ml blood drawn
- Primary outcomeProportion of patients with a complete or partial response
- Secondary outcomeProportion of patients with a complete response
Proportion of patients with a partial response
Proportion of patients with an immune-histochemical improvement in skin biopsies Response duration
Adverse events
- TimepointsT=0 pre-treatment
Monthly until T=13 (1 year follow up)
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. J. Kuball
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Kuball
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryRationale: Currently, there is no established therapy for steroid-refractory chronic GVHD. Manipulation of T cells has not been effective, while there is evidence that manipulation of the B cell compartment leads to clinical improvement.
Objective: To study prospectively the clinical efficacy of Rituximab treatment of steroid refractory chronic GVHD
Study design: Non-randomized phase II single center study
Study population: Patients with a steroid refractory chronic GVHD with skin localization Intervention: Rituximab at a weekly dose of 375 mg/m2 i.v. for four weeks.
Main study parameters/endpoints The primary endpoint of the study will be the proportion of complete and partial responses. The secondary endpoint consists of immune-histochemical improvement in skin biopsies. Nature and extent of the burden and risks associated with participation, benefit and group relatedness. The burden and risks associated with this trial is very low. Potential benefit is that in vivo depletion of B cells with the CD20-specific antibody rituximab may result in amelioration of chronic GVHD symptoms. Side effects of rituximab are mostly associated with the first infusion and usually mild. Blood samples (50 ml each) will be collected at 8 different time points. Skin biopsies will be obtained at 3 different time points.
- Main changes (audit trail)
- RECORD1-feb-2008 - 12-feb-2017


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