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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 | Clinical Trials | Clareo Health

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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

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

NCT01926899•Indiana University

View on ClinicalTrials.gov

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)

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•* Female subject of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse.
•* Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
•* Subjects must be greater than or equal to 1 years old and less 22 years old.
•* Subjects must have any malignant or non-malignant condition that requires treatment with alloHSCT
•* Karnofsky or Lansky performance score greater than 60%
•* Subjects must have a 9 of 10 (HLA A, B, C, DR, and DQ) or 10 of 10 HLA matched-related or MUD for bone marrow or peripheral blood alloHSCT
•* Subjects must meet other institutional criteria for alloHSCT

Exclusion Criteria

•• Patient has greater than 1.5 times upper limit normal (ULN) Total Bilirubin
•* Patient has greater than or equal to Grade 2 peripheral neuropathy
•* Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
•* Patient has hypersensitivity to bortezomib, boron, or mannitol.
•* Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
•* Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable.
•* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
•* Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
•* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
•* Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
+7 more criteria

Locations (2)

Indiana University

Indianapolis, Indiana, United States

Texas Transplant Institute

San Antonio, Texas, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 1, 2018

Completion Date

March 15, 2018

Last Updated

March 22, 2018

Enrollment

ACTUAL participants

Conditions

Hematopoetic Stem Cell Transplant

Interventions

Bortezomib administration

DRUG

Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers

NCT07107165

Stem Cell TransplantHematopoetic Stem Cell Transplant+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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