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Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Weill Medical College of Cornell University
Millennium Pharmaceuticals
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00151320
  Purpose

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 large B cell or mantle cell non-Hodgkin's lymphoma (NHL)

Secondary Objectives:

To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)

Treatment:

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 rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Bortezomib, CHOP, Rituximab
Phase I
Phase II

MedlinePlus related topics:   Lymphoma  

ChemIDplus related topics:   Rituximab   Bortezomib  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

Further study details as provided by Weill Medical College of Cornell University:

Study Start Date:   January 2004

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151320

Locations
United States, Massachusetts
Dana Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
United States, Nebraska
Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198
United States, New York
Weill Medical College of Cornell University    
      New York, New York, United States, 10021
Columbia University College of Physicians and Surgeons    
      New York, New York, United States, 10032

Sponsors and Collaborators
Weill Medical College of Cornell University
Millennium Pharmaceuticals

Investigators
Principal Investigator:     John P Leonard, MD     Weill Medical College of Cornell University    
  More Information

Study ID Numbers:   0903-892, i34103-049
First Received:   September 6, 2005
Last Updated:   October 2, 2007
ClinicalTrials.gov Identifier:   NCT00151320
Health Authority:   United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
diffuse large B cell  
mantle cell lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Bortezomib
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Mantle cell lymphoma
Lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Hemic and Lymphatic Diseases
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 08, 2008