NCT00186667

Brief Summary

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.

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_2

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

September 14, 2005

Last Update Submit

April 7, 2020

Conditions

Graft vs Host DiseaseBlood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

high dose chemotherapy and autologous hematopoietic cell transplantPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ANC \> 1000/mm\^3

You may not qualify if:

  • elevated serum creatinine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Laura Johnston

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

January 1, 1999

Primary Completion

January 1, 2000

Study Completion

September 1, 2005

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

US(1)