Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease

NCT ID: NCT00186667

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2005-09-30

Brief Summary

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Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.

Detailed Description

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An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Conditions

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Graft vs Host Disease Blood and Marrow Transplant (BMT)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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high dose chemotherapy and autologous hematopoietic cell transplant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ANC \> 1000/mm\^3

Exclusion Criteria

* elevated serum creatinine
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Johnston

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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BMT81

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-SQL 75568

Identifier Type: -

Identifier Source: org_study_id

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