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Lymphoma, B CellPhase 2NCT00210379

Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

A Phase 2 study testing rituximab, CHOP and intrathecal methotrexate in people with Lymphoma, B Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Lymphoma, B Cell
What is being tested?
rituximab, CHOP and intrathecal methotrexate
Type of treatment
Surgery or procedure
How many people
64 participants
Where
1 siteSwitzerland
Study dates
Nov 2000to Mar 2007
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age = 18 years.
  • ECOG performance status 0-2
  • Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
  • Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
  • Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
  • Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
Show all 11Show fewer
  • Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
  • No previous therapy with monoclonal antibody anti-CD20.
  • No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
  • No other major life-threatening illnesses that may preclude chemotherapy
  • Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Who cannot join

  • impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement
  • HIV positive patients
  • evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Oncology Institute of Southern Switzerland (IOSI)

    Bellinzona, 6500

Other trials in Switzerland

About this study

Official title: A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

Being tested
rituximab, CHOP, intrathecal methotrexate, radiotherapy
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • rituximabDrug

  • CHOPDrug

  • intrathecal methotrexateDrug

  • radiotherapyProcedure or surgery

What is being measured

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

  1. Disease-free survival

  2. Progression-free survival

  3. Event-free survival

Secondary outcomes (1)

  1. Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startNov 2000
  3. Primary completionNov 2004
  4. Study completionMar 2007

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00210379
Sponsor's protocol ID
IELSG10
Status last verified
Jul 2009
First submitted
13 Sep 2005
Last updated
22 Jul 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, CHOP and intrathecal methotrexate in people with Lymphoma, B Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Switzerland.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease-free survival. The study lists 3 primary outcomes in all. 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 NCT00210379.

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 22 Jul 2009.

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