- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01119794
Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab
Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Hampshire
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Hanover, New Hampshire, United States
- Dartmouth-Hitchcock Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Providence, Rhode Island, United States, 02906
- Miriam Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients are required to have histologically confirmed lymphoma according to the WHO/Revised European-American Lymphoma classification, including B-cell small lymphocytic lymphoma (SLL); marginal zone lymphoma (MZL); follicular lymphoma (FL), grades 1, 2, or 3; mantle cell lymphoma (MCL); and Waldenström macroglobulinemia. Prior history of transformed lymphoma is permitted as long as recent biopsies revealed no evidence of aggressive lymphoma and it has been > 3years since prior aggressive lymphoma
- Patients must measurable disease (defined as 1 cm with spiral computed tomography scan)
- Relapse of disease beyond 6 months after rituximab-containing regimen
- Patients had to have received no more than three prior lines of conventional cytotoxic therapy, and were required to have stopped receiving cytotoxic chemotherapy for at least 4 weeks before study enrollment
- Absolute neutrophil count > 1,500/uL and Platelet > 100,000/uL (if known lymphomatous involvement of the bone marrow, then absolute neutrophil count > 750/uL and platelet count of > 50,000/uL) within 14 days of enrollment.
- Total bilirubin < 1.5 x upper institutional limit of normal (ULN), and AST or ALT < 2.5 x ULN (< 3 x ULN if the patient had liver involvement); alkaline phosphatase < 2.5x upper limit of normal; and a creatinine < 2mg/dl within 14 days of enrollment.
- ECOG performance status 0 to 2
- Minimum life expectancy of 6 months
- Age older than 18 years
- Voluntary, signed 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 is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Exclusion Criteria:
- Subjects who have current active hepatic or biliary disease asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Documented infection with HIV
- Positive serology for Hepatitis B defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
- Central nervous system or meningeal involvement by lymphoma
- Prior transplantation
- Contraindication to any drug contained in the chemotherapy regimens
- Any serious active disease or co-morbid condition that would impair protocol treatment.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal call carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Prior treatment with any anti-CD20 monoclonal antibody, with the exception of rituximab, or any proteasome inhibitor.
- Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), 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 has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. A pregnancy test must be performed within 7 days prior to study drug. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs within 4 weeks before enrollment or 5 half lives of the investigational agent.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ofatumumab and bortezomib
Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression
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Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment
Time Frame: Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years
|
Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only. Complete Response - CR: • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response - PR: • At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable Disease - SD: • A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease Relapsed Disease: • Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. |
Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge Castillo, MD, Lifespan
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BrUOG-NHL-227
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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