Status:
COMPLETED
Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis
Lead Sponsor:
Corewell Health West
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Hematological Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if Bortezomib, known commercially as Velcade is safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be used as graft vers...
Detailed Description
It is hypothesized that the administration of an early and short course cyclophosphamide and bortezomib after allogeneic hematopoietic stem cell transplantationin in the setting of matched related or ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 8 out of 8 matched related or unrelated donor
- Age \> 18 years
- Good performance status with a Karnofsky score \>/= to 70%
- No evidence of progressive bacterial, viral or fungal infection despite adequate treatment
- Creatinine clearance \> 40 mL/min/1.72m2
- Total bilirubin \< 1.5 and ALT and AST \< 2 times the upper limit of normal
- Cardiac ejection fraction \> 40%
- DLCO \> 50%
- Negative pregnancy test
- Negative HIV serology
- Able to provide informed consent
- Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are 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 (ie, 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.
- Exclusion Criteria:
- Age \<18 years
- Poor performance status (\<70%)
- Active infections
- Abnormal creatinine clearance \<40ml/min
- Elevated bilirubin \>1.5 and ALT and AST .2 times the upper limit of normal
- Poor ejection fraction \<40%
- DLCO \<50%
- Pregnant female.
- HIV positive
- Inability to provide informed consent
- Patient has \>/= 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.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for another malignancy within 3 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.
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01860170
Start Date
April 1 2012
End Date
March 1 2018
Last Update
June 2 2023
Active Locations (1)
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1
Spectrum Health
Grand Rapids, Michigan, United States, 49503