Other Clinical Trial - A Multicenter Phase I Study Evaluating the Addition

A Multicenter Phase I Study Evaluating the Addition of Bortezomib to an Established Acute Graft Versus Host Disease Prophylaxis Regimen in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients

Hematopoetic Stem Cell Transplant Clinical Trial

Official title:
A Multicenter Phase I Study Evaluating the Addition of Bortezomib to an Established Acute Graft Versus Host Disease (aGVHD) Prophylaxis Regimen in Pediatric Allogeneic Hematopoietic Stem Cell Transplant (Allo HSCT) Patients

Clinical Trial Summary

The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in combination with calcineurin inhibitor and methotrexate as acute graft versus host disease (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell transplant (alloHSCT)

See also
	Status	Clinical Trial	Phase
	Not yet recruiting	`NCT05302583` - Aromatherapy Inhaler Use for HSCT Distress	N/A

See also

Status

Clinical Trial

Phase

Not yet recruiting

NCT05302583 - Aromatherapy Inhaler Use for HSCT Distress

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01926899
Study type	Interventional
Source	Indiana University
Contact
Status	Completed
Phase	Phase 1
Start date	August 1, 2013
Completion date	March 15, 2018

A Multicenter Phase I Study Evaluating the Addition of Bortezomib to an Established Acute Graft Versus Host Disease Prophylaxis Regimen in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms