VELCADE,Rituximab,Cyclophosphamide and Decadron

NCT00413959 | Terminated Phase 2 Results

• 1 other identifier: 0606
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Keywords

NHL

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.

  Percentage of complete responders plus percentage of partial responders equals overall response rate.

  4 years

Secondary Outcomes (1)

• Overall Survival

  4 years

Study Arms (1)

Velcade, Rituximab,Cyclophosphamide & Decadron

EXPERIMENTAL

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.

Drug: VELCADE®; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Decadron

Interventions

VELCADE® DRUG

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

Also known as: Bortezomib

Velcade, Rituximab,Cyclophosphamide & Decadron

Rituximab 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.

Also known as: Rituxan

Velcade, Rituximab,Cyclophosphamide & Decadron

Cyclophosphamide DRUG

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

Also known as: Cytoxan

Velcade, Rituximab,Cyclophosphamide & Decadron

Decadron DRUG

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

Also known as: dexamethasone

Velcade, Rituximab,Cyclophosphamide & Decadron

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known HIV positive status
• Known CNS involvement
• Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Onocology Specialists, S.C

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

Bortezomib; Rituximab; Cyclophosphamide; Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Sigrun Hallmeyer, MD Director of Research
• Organization: Oncology Specialists SC

shallmeyer@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 19, 2018
• Results First Posted: September 27, 2013

Record last verified: 2018-08

Locations

US (2)