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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.
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: 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
Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase III

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

Resource links provided by NLM:


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

Additional Information:
No publications provided

Study ID Numbers: CDR0000069122, CKTO-2000-10, HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10
Study First Received: January 4, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00028717     History of Changes
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

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

ClinicalTrials.gov processed this record on November 27, 2009