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Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119794
Recruitment Status : Terminated (lack of accrual)
First Posted : May 10, 2010
Results First Posted : August 11, 2015
Last Update Posted : August 26, 2015
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Eric Winer, MD, Brown University

Brief Summary:
The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkins Drug: Ofatumumab and Bortezomib Phase 2

Detailed Description:
41 patients will be enrolled in this trial with low grade lymphomas and will be given Ofatumumab 1000 mg and Bortezomib IV 1.6 mg/m2 weekly times 4 treatments and will then receive maintenance treatment with the 2 agents every 2 months for 1 year unless disease progression.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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
Drug: 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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01119794

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Hanover, New Hampshire, United States
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Dartmouth-Hitchcock Medical Center
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Principal Investigator: Jorge Castillo, MD Lifespan

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Responsible Party: Eric Winer, MD, PI, Brown University Identifier: NCT01119794     History of Changes
Other Study ID Numbers: BrUOG-NHL-227
First Posted: May 10, 2010    Key Record Dates
Results First Posted: August 11, 2015
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by Eric Winer, MD, Brown University:
B-cell small lymphocytic lymphoma
marginal zone lymphoma
follicular lymphoma
mantle cell lymphoma
Waldenström macroglobulinemia.
Low Grade B cell Non-Hodgkins Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs