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

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: January 8, 2014
Last verified: January 2014
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 Intervention Phase
Non-Hodgkins Lymphoma
Drug: Cyclophosphamide
Drug: Mitoxantrone
Drug: Vincristine
Drug: Prednisone
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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.

Enrollment: 51
Study Start Date: April 2003
Study Completion Date: February 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193479     History of Changes
Other Study ID Numbers: SCRI LYM 28
Study First Received: September 12, 2005
Results First Received: January 8, 2014
Last Updated: January 8, 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 processed this record on April 28, 2017