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LymphomaPhase 3NCT00028717

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

A Phase 3 study testing filgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Commissie Voor Klinisch Toegepast Onderzoek at 13 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and cyclophosphamide
How many people
400 participants
Where
13 sitesNetherlands
Study dates
Feb 2001to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Netherlands13 sites

  • Meander Medisch Centrum

    Amersfoort, 3816 CP

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081HV

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • University Medical Center Groningen

    Groningen, 9713 EZ

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • HagaZiekenhuis - Locatie Leyenburg

    The Hague, 2545 CH

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Isala Klinieken - locatie Sophia

    Zwolle, 8000 GK

Other trials in Netherlands

About this study

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

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.

Read the 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.

Conditions
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
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

Secondary outcomes (4)

  1. Complete response

  2. Overall survival

  3. Disease-free interval

  4. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028717
Sponsor's protocol ID
CDR0000069122
Other IDs
CKTO-2000-10, HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10
Status last verified
Nov 2007
First submitted
4 Jan 2002
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Commissie Voor Klinisch Toegepast Onderzoek at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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