Bortezomib in Treating Patients With Lymphoproliferative Disorders
Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders
11 other identifiers
interventional
103
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
April 1, 2014
CompletedDecember 8, 2015
December 1, 2012
7.8 years
September 13, 2001
October 23, 2013
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Response Rate
The response probability will be estimated. The 95% confidence interval will be provided.
Up to 3 years
Study Arms (1)
Arm I
EXPERIMENTALPatients receive an infusion of bortezomib (dose of 1.8 mg/m2) over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Gerecitano
- Organization
- Memorial Sloan-Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
John Gerecitano
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2001
First Posted
January 27, 2003
Study Start
June 1, 2001
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 8, 2015
Results First Posted
April 1, 2014
Record last verified: 2012-12