VELCADE,Rituximab,Cyclophosphamide and Decadron

NCT ID: NCT00413959

Last Updated: 2018-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-01-31

Brief Summary

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Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

Detailed Description

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This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

Conditions

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Lymphoma, Non-Hodgkin Lymphoma, B-Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Velcade, Rituximab,Cyclophosphamide & Decadron

Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.

Group Type EXPERIMENTAL

VELCADE®

Intervention Type DRUG

1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.

Rituximab

Intervention Type DRUG

375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.

Cyclophosphamide

Intervention Type DRUG

400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.

Decadron

Intervention Type DRUG

40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23

Interventions

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VELCADE®

1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.

Intervention Type DRUG

Rituximab

375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.

Intervention Type DRUG

Cyclophosphamide

400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.

Intervention Type DRUG

Decadron

40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23

Intervention Type DRUG

Other Intervention Names

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Bortezomib Rituxan Cytoxan dexamethasone

Eligibility Criteria

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Inclusion Criteria

* Small Lymphocytic Lymphoma
* Follicular Cell Lymphoma (grades I and II)
* Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
* Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
* Marginal Zone Lymphoma
* MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
* Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
* ECOG performance status of 0, 1, or 2
* Able to read, understand, and sign an IRB approved informed consent

Exclusion Criteria

* Known HIV positive status
* Known CNS involvement
* Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Oncology Specialists, S.C.

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sigrun Hallmeyer

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chadi Nabhan, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Specialists, SC

Locations

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Onocology Specialists, S.C

Niles, Illinois, United States

Site Status

Oncology Specialists, S.C

Park Ridge, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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0606

Identifier Type: -

Identifier Source: org_study_id

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