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Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy

Phase 1
18 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy

Inclusion Criteria:

- Patients must have histologically proven relapsed or refractory MCL, DLBCL including
subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell
and anaplastic large B cell lymphoma, or low grade B cell NHL.

- Patients must have received prior systemic therapy for their lymphoma.

- Age >18 years.

- Life expectancy of greater than 12 weeks

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents.

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to bortezomib or boron.

- Previous radiation therapy to the maximum tissue tolerance at any site.

- Previous autologous or allogeneic stem cell transplantation.

- Involvement of the bone marrow of >25% by lymphoma.

- Known involvement of the central nervous system by lymphoma. 17

- Significant organ dysfunction, including hematologic (absolute neutrophil count
<1500, platelets <150,000).

- ECOG performance status >2.

- Uncontrolled illness including, but not limited to, ongoing or active
infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- HIV infection.

- 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.

- Myocardial infarction within 3 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 bortezomib, boron or mannitol.

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum β-human chorionic gonadotropin
(β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.

Type of Study:


Study Design:

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

Outcome Measure:

The primary objectives of this study are to determine: a) The appropriate doses of bortezomib and 131I-tositumomab when used in combination. b) Toxicities of the combination treatment.

Outcome Time Frame:

throughout dose escalation treatments

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • relapsed non-Hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Michigan Ann Arbor, Michigan  48109-0624
Weill Cornell Medical College New York, New York  10021