NCT04154735

Autologous Transplant Targeted Against Crohn's

Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This study is a new Phase II trial to assess the toxicity and efficacy of autologous hematopoietic stem cell transplantation (HSCT) utilizing a new non-myeloablative conditioning regimen in patients with high-risk Crohn's disease (CD). The regimen will include low-dose immunosuppressive therapy and a targeted antibiotic for six to twelve months post-HSCT.

Detailed description

The autologous hematopoietic stem cell transplantation (HSCT) in this study utilizes a new non-myeloablative conditioning regimen in patients with high-risk Crohn's disease (CD). The regimen includes two types of chemotherapy (cyclophosphamide and fludarabine) as well as alemtuzumab. The regimen will include low-dose immunosuppressive therapy with tacrolimus (Prograf) for one year post-HSCT in attempt to prevent relapse and improve long-term remission. Patients will also receive rifaximin (Xifaxan) for six months post-HSCT to target abnormal intestinal microbiota that may trigger intestinal inflammation. The ability of these experimental treatments to stop relapses and progression (worsening) of Crohn's disease will be assessed.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Fludarabine	A chemotherapy medication commonly used in the treatment of leukemia and lymphoma
DRUG	Cyclophosphamide	A medication used as chemotherapy and to suppress the immune system
DRUG	Mesna	A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
DRUG	Alemtuzumab	A protein that kills the immune cells that are thought to be causing Crohn's; it is commonly used in the treatment of leukemia and lymphoma
DRUG	G-CSF	A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
DRUG	Rifaximin	An antibiotic used to treat irritable bowel syndrome and relapsing C. difficile infection; it inhibits DNA-dependent RNA polymerase
DRUG	Tacrolimus	A medication which suppresses the immune system and inhibits T-lymphocytes; commonly used to lower the risk of organ rejection following transplant

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2019-11-06
• Last updated: 2019-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study