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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

NCT01926899 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-03-22

No results posted yet for this study

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)

Conditions

  • Hematopoetic Stem Cell Transplant

Interventions

DRUG

Bortezomib administration

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-01
Primary Completion
2018-02-01
Completion
2018-03-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01926899 on ClinicalTrials.gov