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- Klinische proef NCT00079183
Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment
A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-versus-Host Disease
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD.
II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment.
OUTLINE:
Patients receive sirolimus orally (PO) once daily (QD). Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician.
After completion of study treatment, patients are followed up periodically.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of
- Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or
- Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or
- Absence of improvement after 3 months of primary treatment, or
- Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen
- Patient or guardian able and willing to provide informed consent
- Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration [FDA] requirement)
- Stated willingness of the patient to comply with study procedures and reporting requirements
- Stated willingness of the physician most involved in management of chronic GVHD (the "managing physician,") to comply with study procedures and reporting requirements
Exclusion Criteria:
- Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy
- Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy
- Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions
- Inability to tolerate oral medications
- Absolute neutrophil count (ANC) < 1500/uL
- Platelet count < 50,000/uL
- Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled
- Pregnancy
- Known history of hypersensitivity to sirolimus
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Sirolimus
Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician.
Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started.
Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
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Gegeven PO
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants Experiencing Treatment Success
Tijdsspanne: Approximately 7 years
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Defined as the absence of any immunosuppressive treatment, including sirolimus, with resolution of all reversible manifestations of chronic GVHD and no additional systemic therapy.
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Approximately 7 years
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Number of Participants Experiencing Treatment Failure
Tijdsspanne: Approximately 7 years
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Defined as the initiation of additional systemic therapy, development of bronchiolitis obliterans, or death from causes other than recurrent malignancy during primary treatment for chronic GVHD, whichever occurs first.
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Approximately 7 years
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Number of Participants Needing Additional Systemic Therapy
Tijdsspanne: Approximately 7 years
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Includes any intervention intended to control chronic GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not originally given under auspices of this protocol.
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Approximately 7 years
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Number of Participants With Recurrent Malignancy
Tijdsspanne: Approximately 7 years
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Defined as clinical or histopathologic evidence demonstrating the presence of any malignancy considered as the indication for transplant.
Recurrent malignancy will also be defined as any post-transplant intervention not routinely used to prevent the development of overt recurrence, prompted by laboratory evidence of persisting malignant cells but without clinical or histopathologic evidence of recurrence.
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Approximately 7 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Proportion of Patients Who Discontinue Administration of Sirolimus Because of Toxicity
Tijdsspanne: Approximately 7 years
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Approximately 7 years
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Proportion With Infections Categorized by Organism
Tijdsspanne: Approximately 7 years
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Approximately 7 years
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Secondary Malignancies
Tijdsspanne: Up to 7 years
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Proportion of participants who developed at least one secondary malignancy by 7 years
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Up to 7 years
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Duration of Treatment With Prednisone
Tijdsspanne: Approximately 7 years
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Approximately 7 years
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Probability of Survival Without Recurrent Malignancy
Tijdsspanne: Approximately 7 years
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Kaplan-Meier estimate assessed at 7 years for probability of survival without recurrent malignancy.
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Approximately 7 years
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Probability of Overall Survival
Tijdsspanne: Approximately 7 years
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Kaplan-Meier estimate assessed at 7 years
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Approximately 7 years
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Probability of Cumulative Incidence of Death Without Recurrent Malignancy
Tijdsspanne: Approximately 7 years
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Analyzed with recurrent malignancy as a competing risk factor.
Assessed at 7 years.
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Approximately 7 years
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Probability of Cumulative Incidence of Recurrent Malignancy
Tijdsspanne: Approximately 7 years
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Analyzed with death as a competing risk factor.
Assessed at 7 years.
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Approximately 7 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1706.00
- NCI-2011-01817 (Register-ID: CTRP (Clinical Trial Reporting Program))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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AltruBio Inc.VoltooidSteroïde-refractaire acute graft-versus-host-ziekte | Behandeling-refractaire acute graft-versus-host-ziekteVerenigde Staten
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moshe yeshurunOnbekendAcute-graft-versus-host-ziekteIsraël
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