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Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma

Phase 2
18 Years
Open (Enrolling)
Lymphoma, Non-Hodgkins

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Trial Information

Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma

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

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

- 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withdrawn by the subject at any time without prejudice to future medical care.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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure Response Rate

Outcome Time Frame:

13 months unless progression

Safety Issue:


Principal Investigator

Jorge Castillo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2013

Related Keywords:

  • Lymphoma, Non-Hodgkins
  • B-cell small lymphocytic lymphoma
  • marginal zone lymphoma
  • follicular lymphoma
  • mantle cell lymphoma
  • Waldenström macroglobulinemia.
  • Low Grade B cell Non-Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Rhode Island Hospital Providence, Rhode Island  02903
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Miriam Hospital Providence, Rhode Island  02906