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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Weill Medical College of Cornell University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Millennium Pharmaceuticals, Inc.

Information provided by:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00151320

First received: September 6, 2005

Last updated: July 27, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

July 27, 2010

Start Date ^ICMJE

January 2004

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00151320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

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 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: Bortezomib, CHOP, Rituximab

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00151320

Other Study ID Numbers ^ICMJE

0309006313, i34103-049

Has Data Monitoring Committee

Not Provided

Responsible Party

John P. Leonard, MD, Weill Cornell Medical College

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Millennium Pharmaceuticals, Inc.

Investigators ^ICMJE

Principal Investigator:

John P Leonard, MD

Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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