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

This study has been completed.
Sponsor:
Collaborators:
Genentech
Amgen
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193479
First received: September 12, 2005
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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
Cyclophosphamide
Other Name: Cytoxan
Drug: Mitoxantrone
Mitoxantrone
Other Name: Novantrone
Drug: Vincristine
Vincristine
Other Name: Oncovin
Drug: Prednisone
Prednisone
Drug: Rituximab
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193479

Locations
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
Amgen
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Mitoxantrone
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 22, 2014