Status:
UNKNOWN
Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I/II trial of bortezomib, cladribine, and rituximab in newly diagnosed and relapsed mantle cell lymphoma (MCL). The phase I component has three dose levels of cladribine (3 mg/m2, 4 mg...
Detailed Description
The phase I portion of the study is a standard dose-escalation schemed designed to determine the maximum tolerated dose (MTD) of the combination of bortezomib, cladribine, and rituximab therapy. The M...
Eligibility Criteria
Inclusion
- Females that are postmenopausal for at least 1 year before the screening visit, 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.
- Male subjects must agree to 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.
- Patients with newly diagnosed and relapsed mantle cell lymphoma.
- ECOG performance status grade 3 or higher.
Exclusion
- Patient has a platelet count of \<50x10 9/L within 14 days before enrollment if not related to disease.
- Patient has an absolute neutrophil count less than 100 within 14 days before enrollment if not related to disease.
- Patient has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment.
- Patient has \> Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has \> 1.5 x ULN total bilirubin.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association Class II or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding.
- Patient has received other investigational drugs within 14 days before enrollment.
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01439750
Start Date
May 1 2012
End Date
August 1 2020
Last Update
August 7 2017
Active Locations (2)
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1
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033