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

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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.

Study NCT00151320. Last updated on October 2, 2007. Information provided by Weill Medical College of Cornell University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Non-Hodgkin's Lymphoma

Intervention ^†

Drug: Bortezomib, CHOP, Rituximab

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

January 2004

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00151320

Organization ID

0903-892

Secondary IDs ^††

i34103-049

Study Sponsor ^†

Weill Medical College of Cornell University

Collaborators ^††

Millennium Pharmaceuticals, Inc.

Investigators ^†

Principal Investigator:

John P Leonard, MD

Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

October 2007

First Received Date ^†

September 6, 2005

Last Updated Date

October 2, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.