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

Sponsor:	Weill Medical College of Cornell University
Collaborator:	Millennium Pharmaceuticals, Inc.
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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Bortezomib

U.S. FDA Resources

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

Primary Outcome Measures:

determine maximum tolerated dose [ Time Frame: phase I ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	78
Study Start Date:	January 2004
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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, Inc.

Investigators

Principal Investigator:

John P Leonard, MD

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	John P. Leonard, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT00151320 History of Changes
Other Study ID Numbers:	0309006313, i34103-049
Study First Received:	September 6, 2005
Last Updated:	July 27, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

diffuse large B cell
mantle cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bortezomib

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 13, 2012