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Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsored by: Commissie Voor Klinisch Toegepast Onderzoek
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028717
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: filgrastim
Drug: prednisone
Drug: rituximab
Drug: vincristine sulfate
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Filgrastim    Prednisone    Vincristine sulfate    Vincristine    Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-free interval [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:   400
Study Start Date:   February 2001

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkin's lymphoma.
  • Compare the complete remission rate, overall survival, and disease-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO classification, and International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

  Eligibility
Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma (NHL)

    • Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:

      • Mantle cell lymphoma
      • Follicular lymphoma (grade III)
      • Diffuse large B-cell lymphoma
  • CD20-positive
  • No suspected or documented CNS involvement by NHL NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 65 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 1.75 mg/dL*
  • Transaminases less than 2.5 times normal* NOTE: * Unless due to NHL

Renal:

  • Creatinine less than 1.7 mg/dL (unless due to NHL)

Cardiovascular:

  • No severe cardiac dysfunction
  • No New York Heart Association class II-IV heart disease
  • LVEF at least 45%

Pulmonary:

  • No uncontrolled asthma requiring steroid treatment

Other:

  • HIV negative
  • No intolerance to exogenous protein administration
  • No active, uncontrolled infection
  • No uncontrolled allergy requiring steroid treatment
  • No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for NHL

Chemotherapy:

  • No prior chemotherapy for NHL

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration
  • Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028717

Locations
Netherlands
Academisch Medisch Centrum at University of Amsterdam    
      Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Maastricht    
      Maastricht, Netherlands, 6202 AZ
Daniel Den Hoed Cancer Center at Erasmus Medical Center    
      Rotterdam, Netherlands, 3008 AE
HagaZiekenhuis - Locatie Leyenburg    
      's-Gravenhage, Netherlands, 2545 CH
Isala Klinieken - locatie Sophia    
      Zwolle, Netherlands, 8000 GK
Leiden University Medical Center    
      Leiden, Netherlands, 2300 RC
Vrije Universiteit Medisch Centrum    
      Amsterdam, Netherlands, 1081HV
Medisch Spectrum Twente    
      Enschede, Netherlands, 7500 KA
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital    
      Amsterdam, Netherlands, 1066 CX
Sint Antonius Ziekenhuis    
      Nieuwegein, Netherlands, 3435 CM
University Medical Center Groningen    
      Groningen, Netherlands, 9713 EZ
University Medical Center Utrecht    
      Utrecht, Netherlands, 3584 CX
Meander Medisch Centrum    
      Amersfoort, Netherlands, 3816 CP

Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek

Investigators
Study Chair:     Pieter Sonneveld, MD, PhD     Daniel Den Hoed Cancer Center at Erasmus Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069122, CKTO-2000-10, HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10
First Received:   January 4, 2002
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00028717
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I grade 3 follicular lymphoma  
stage I adult diffuse large cell lymphoma  
stage III grade 3 follicular lymphoma  
stage III adult diffuse large cell lymphoma  
stage IV grade 3 follicular lymphoma  
stage IV adult diffuse large cell lymphoma  
stage I mantle cell lymphoma  
contiguous stage II grade 3 follicular lymphoma  
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:
Prednisone
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Vincristine
Cyclophosphamide
Mantle cell lymphoma
Doxorubicin
Antibodies, Monoclonal
Lymphoma, large-cell
Lymphatic Diseases
Antibodies
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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