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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00186667

Enrollment

Registered

2005-09-16

Start date

1999-01-31

Completion date

2005-09-30

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood and Marrow Transplant (BMT), Graft vs Host Disease

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.

Detailed description

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

Interventions

PROCEDUREhigh dose chemotherapy and autologous hematopoietic cell transplant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

- active chronic GvHD * ANC \> 1000/mm\^3 * therapeutic cyclosporine

Exclusion criteria

- uncontrolled systemic infection * elevated serum creatinine

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026