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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
filgrastim
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
Commissie Voor Klinisch Toegepast Onderzoek
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HagaZiekenhuis - Locatie Leyenburg
  • Meander Medisch Centrum
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Vrije Universiteit Medisch Centrum
  • Academisch Medisch Centrum at University of Amsterdam
  • Medisch Spectrum Twente
  • University Medical Center Groningen
  • Leiden University Medical Center
  • Academisch Ziekenhuis Maastricht
  • Sint Antonius Ziekenhuis
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • University Medical Center Utrecht
  • Isala Klinieken - locatie Sophia

Outcomes

Primary Outcome Measures

Event-free survival

Secondary Outcome Measures

Complete response
Overall survival
Disease-free interval
Toxicity

Full Information

First Posted
January 4, 2002
Last Updated
September 16, 2013
Sponsor
Commissie Voor Klinisch Toegepast Onderzoek
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1. Study Identification

Unique Protocol Identification Number
NCT00028717
Brief Title
Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Commissie Voor Klinisch Toegepast Onderzoek

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Primary Outcome Measure Information:
Title
Event-free survival
Secondary Outcome Measure Information:
Title
Complete response
Title
Overall survival
Title
Disease-free interval
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter Sonneveld, MD, PhD
Organizational Affiliation
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
HagaZiekenhuis - Locatie Leyenburg
City
's-Gravenhage
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3816 CP
Country
Netherlands
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum at University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Isala Klinieken - locatie Sophia
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands

12. IPD Sharing Statement

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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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