CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
bortezomibdrug
Likely dose
Bortezomib given IVAI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed relapsed or refractory grade I, II, or III follicular center cell lymphoma OR relapsed or refractory mantle cell lymphoma
  • ✓Measurable disease: at least 1 unidimensionally measurable lesion ≥2 cm by conventional techniques OR ≥1 cm by spiral CT scan
  • ✓Karnofsky performance status 70-100%
  • ✓Absolute neutrophil count >1,500/mm³ (or >500/mm³ if lymphomatous involvement of bone marrow)
Key exclusion· 9
  • ✕Known brain metastases
  • ✕Symptomatic congestive heart failure or NYHA class III or IV heart disease
  • ✕Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within 6 months
  • ✕Cerebrovascular accident or transient ischemic attack within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00023764
NCT00023764Phase 2Completed
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Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Dec 8, 2015

In Brief

A Phase 2 clinical trial evaluating bortezomib for Recurrent Grade 1 Follicular Lymphoma and 3 related conditions. Completed, enrolled 103 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2001
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 23.4 years ago

Interventions

bortezomibdrug

Given IV