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A clinico-pathologic study of Primary Mediastinal B-cell lymphoma

A clinico-pathologic study of Primary Mediastinal B-cell lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88720356
Enrollment
120
Registered
2010-03-31
Start date
2009-01-16
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

lymphoma, diffuse large B-cell lymphoma Follow Up Length: 120 month(s) Study Entry: Registration only

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum. 2. No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms. 3. Any stage of disease 4. Age at least 18 years 5. Fit to receive chemotherapy with curative intent 6. Able and willing to give informed consent, and to undergo staging including PET scanning 7. Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men

Exclusion criteria

Exclusion criteria: 1. Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry 2. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease 3. Impairment of bone marrow function (WBC 2 x upper normal) or liver function (ASAT/ALAT > 2.5 x upper normal, total bilirubin > 2.5 x upper normal), unless due to lymphoma involvement 5. Known HIV infection. Patients will not be tested routinely. 6. Pregnant or lactating women 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Design outcomes

Primary

MeasureTime frame
Response rate on PET scanning following initial chemotherapy and at the end of all treatment

Secondary

MeasureTime frame
1. Progression Free Survival 2. Overall Survival

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026