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

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

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