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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:1 - 21
Updated:4/17/2018
Start Date:August 1, 2013
End Date:March 15, 2018

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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

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)


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not part of normal medical care, with the understanding that consent may be withdrawn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.

- Current active infection per physician determination

- HIV positive

- Previous myeloablative autoHSCT or alloHSCT in previous 12 months

- ALT and AST greater than 5 times ULN for age

- Creatinine clearance or glomerular filtration rate (GFR) less than 60 ml/min/1.73

- Shortening fraction less than 26% or ejection fraction less than 45%

- Diffusing capacity of carbon monoxide (DLCO), volume exhaled at end of first
second of forced expiration (FEV1), diffusion capacity less than 50% of predicted
(corrected for hemoglobin); if unable to perform lung function tests, oxygen
saturation less than 94% on room air
We found this trial at
2
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: David Delgado, MD
Phone: 317-944-8784
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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San Antonio, Texas 78229
Phone: 210-575-7348
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