Phase 2
N=103
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
Bottom Line
View on ClinicalTrials.gov: NCT00023764 ↗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
| Outcome | Result | p-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
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.