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

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ClinicalTrials.gov Identifier: NCT00028717
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : February 2001





Primary Outcome Measures :
  1. Event-free survival

Secondary Outcome Measures :
  1. Complete response
  2. Overall survival
  3. Disease-free interval
  4. Toxicity


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00028717


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

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ClinicalTrials.gov Identifier: NCT00028717     History of Changes
Other Study ID Numbers: CDR0000069122
CKTO-2000-10
HOVON-46NHL
EU-20130
HOVON-CKVO-2000-10
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: November 2007

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

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine
Liposomal doxorubicin
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents