Status:
COMPLETED
Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objective: To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse l...
Detailed Description
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE is administered prior to r...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of diffuse large B cell or mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).
- Patient has not received any prior anti-cancer therapy for lymphoma
- Tumor tissue confirmed to express the CD20 antigen
- Available frozen tumor tissue(rebiopsy if needed)
- Patient has measurable disease as defined by a tumor mass \> 1.5 cm
- Patient has Stage II, III, or IV disease
- Age \> 18 years
- Absolute granulocyte count \> 1000 cells/mm3
- Platelet count \> 50,000 cells/mm3
- Creatinine \< 2.0 x ULN
- Total bilirubin \< 2.0 x ULN
Exclusion
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Patient is pregnant or nursing
- Patient has had major surgery within the last 3 weeks
- Patient is receiving other investigational drugs
- Known peripheral neuropathy \> Grade 2
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00151320
Start Date
January 1 2004
End Date
April 24 2013
Last Update
June 19 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
Weill Medical College of Cornell University
New York, New York, United States, 10021
4
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032