TrialSignal
Clinical trial intelligence report
A Phase I/II Study of Sirolimus in Addition to Tacrolimus and Methotrexate for the Prevention of Acute-Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation From Unrelated Donors
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT00089037-Jun 25, 2026
NCT ID
NCT00089037
Status
COMPLETED
Phase
Phase 1/2
Sponsor
Fred Hutchinson Cancer Center
Executive brief
Investment-Ready Snapshot
The study, sponsored by Fred Hutchinson Cancer Center, aims to evaluate the safety and efficacy of a combination regimen of sirolimus, tacrolimus, and methotrexate in preventing acute GVHD in patients undergoing hematopoietic stem cell transplantation from unrelated donors. The market for GVHD prevention therapies is significant, driven by the increasing incidence of hematological malignancies and the growing number of stem cell transplants. Competitive analysis indicates that while several therapies are available, the unique combination of these agents may offer improved outcomes, particularly in high-risk patient populations. Diligence implications include the need for thorough evaluation of safety profiles and potential market entry strategies, especially considering the existing therapies in the GVHD prevention landscape.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00089037
Indication
Chronic Myeloproliferative Disorders
Modality
small molecule
Target
Sirolimus (mTOR inhibitor), Tacrolimus (calcineurin inhibitor), Methotrexate (antimetabolite) - targeting pathways involved in T-cell activation and proliferation to prevent acute graft-versus-host disease (GVHD).
Intervention
methotrexate, sirolimus, tacrolimus
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.