Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193479
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Condition or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Drug: Cyclophosphamide Drug: Mitoxantrone Drug: Vincristine Drug: Prednisone Drug: Rituximab Phase 2

Detailed Description:

Upon determination of eligibility, patients will receive:

  • Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab

Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma
Study Start Date : April 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone
All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.
Drug: Cyclophosphamide
Other Name: Cytoxan
Drug: Mitoxantrone
Other Name: Novantrone
Drug: Vincristine
Other Name: Oncovin
Drug: Prednisone
Drug: Rituximab
Other Name: Rituxan

Primary Outcome Measures :
  1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 Months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma
  • No previous treatment
  • Clinical stage II, III, or IV by the Ann Arbor Staging Criteria
  • Age > 70 years
  • ECOG performance status 0, 1, or 2
  • Adequate bone marrow, liver and kidney function
  • Must give written informed consent prior to entering this trial

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • Central nervous system involvement with lymphoma
  • Coexistent active malignancies treated within five years
  • Active infection precluding the use of combination chemotherapy
  • HIV infection
  • Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193479

United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193479     History of Changes
Other Study ID Numbers: SCRI LYM 28
First Posted: September 19, 2005    Key Record Dates
Results First Posted: February 21, 2014
Last Update Posted: February 21, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators