Lymphoma, B CellPhase 2NCT00210314
Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
A Phase 2 study testing high dose methotrexate, high dose cytarabine and radiotherapy in people with Lymphoma, B Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Switzerland.
Trial summary
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, B Cell
- What is being tested?
- high dose methotrexate, high dose cytarabine and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2003to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of non-Hodgkin's lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- Disease exclusively localized into the central nervous system, cranial nerves or eyes.
- Untreated patients (patients treated with steroids alone are eligible).
- At least one measurable lesion.
- Age 18 - 75 years.
Show all 15Show fewer
- ECOG performance status < 3
- HBsAg-negative and Ab anti-HCV-negative serologic status.
- No known HIV disease or immunodeficiency.
- Adequate bone marrow (PLT > 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).
- No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- No concurrent treatment with other experimental drugs.
- Informed consent signed by the patient before registration
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
About this study
Official title: Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma
- Conditions
- Lymphoma, B Cell
- Being tested
- high dose methotrexate, high dose cytarabine, 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.
high dose methotrexateDrug
high dose cytarabineDrug
radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| High-dose methotrexate alone | Active comparator | Not described Receives: Drug: high dose methotrexate; Radiation: radiotherapy |
| High-dose methotrexate associated with high dose cytarabine | Experimental | Not described Receives: Drug: high dose methotrexate; Drug: high dose cytarabine; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoint is the complete remission (CR) rate after chemotherapy
Secondary outcomes (6)
Overall response rate
Response duration (time to relapse or progression) for responder patients
Overall survival
Event-free survival
Meningeal relapse rate
Early and late neurotoxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, B CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Investigators
- Andres JM Ferreri, MD, Study chair, Radiochemotherapy. San Raffaele Hospital. MilanMichele Reni, MD, Study chair, Radiochemotherapy. San Raffaele Hospital. MilanEmanuele Zucca, MD, Study chair, International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210314
- Sponsor's protocol ID
- IELSG20
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2015
- Results posted
- No
Publications
Ferreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18.
PubMed 19767089
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT00210314
- Acronym / sponsor ID
- IELSG20
- Conditions
- Lymphoma, B Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Jul 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose methotrexate alone | Active comparator | Drug: high dose methotrexate, Radiation: radiotherapy |
| High-dose methotrexate associated with high dose cytarabine | Experimental | Drug: high dose methotrexate, Drug: high dose cytarabine, Radiation: radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological or cytological diagnosis of non-Hodgkin's lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- Disease exclusively localized into the central nervous system, cranial nerves or eyes.
- Untreated patients (patients treated with steroids alone are eligible).
- At least one measurable lesion.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose methotrexate | Drug | High-dose methotrexate alone, High-dose methotrexate associated with high dose cytarabine |
| high dose cytarabine | Drug | High-dose methotrexate associated with high dose cytarabine |
| radiotherapy | Radiation | High-dose methotrexate alone, High-dose methotrexate associated with high dose cytarabine |
Primary outcome
The main endpoint is the complete remission (CR) rate after chemotherapy
6 secondary outcomes
Overall response rate
Response duration (time to relapse or progression) for responder patients
Overall survival
Event-free survival
Meningeal relapse rate
Early and late neurotoxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Derived from this study: PubMed 19767089Ferreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18.
- Click here for more information about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres JM Ferreri, MD study chair
Radiochemotherapy. San Raffaele Hospital. Milan
Michele Reni, MD study chair
Radiochemotherapy. San Raffaele Hospital. Milan
Emanuele Zucca, MD study chair
International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high dose methotrexate, high dose cytarabine and radiotherapy 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 15 inclusion and 0 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 30 Mar 2015. 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?
The main endpoint is the complete remission (CR) rate after chemotherapy. 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 NCT00210314, which also lists 1 linked publication.
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 30 Mar 2015.