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Phase 2 N=103 Treatment

Bortezomib in Treating Patients With Lymphoproliferative Disorders

Recurrent Grade 1 Follicular Lymphoma · Recurrent Grade 2 Follicular Lymphoma · Recurrent Grade 3 Follicular Lymphoma · Recurrent Mantle Cell Lymphoma

Enrolled (actual)
103
Serious AEs
19.4%
Results posted
Apr 2014
Primary outcome: Primary: Response Rate — 11; 6 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bortezomib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Mar 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Response Rate
11; 6

Summary

Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Eligibility Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes:
  • * Relapsed or refractory grade I, II, or III follicular center cell lymphoma
  • Relapsed or refractory mantle cell lymphoma
  • Measurable disease for non-Hodgkin's lymphoma (NHL) only
  • At least 1 unidimensionally measurable lesion
  • At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan
  • Lymph nodes no greater than 1 cm in short axis considered normal
  • Absolute lymphocytosis greater than 5, 000/mm^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL
  • No known brain metastases
  • Performance status - Karnofsky 70-100%
  • At least 3 months
  • See Disease Characteristics
  • Absolute neutrophil count greater than 1, 500/mm^3 (500/mm^3 if lymphomatous involvement of bone marrow)
  • Platelet count greater than 50,000/mm^3
  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)
  • Creatinine less than 1.5 times ULN
  • No symptomatic congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No cerebrovascular accident or transient ischemic attack within the past 6 months
  • No history of orthostatic hypotension
  • No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram
  • No uncontrolled hypertension requiring antihypertensive medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Febrile episodes up to 38.5°C allowed if no evidence of active infection
  • No other uncontrolled concurrent illness
  • No known or active HIV infection
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study entry
  • At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)
  • No more than 3 prior regimens of conventional cytotoxic chemotherapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • At least 1 week since prior steroid therapy
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior major surgery
  • No other concurrent investigational agents
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00023764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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