New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System In… (NCT02329080) | Clinical Trial Compass
CompletedPhase 2
New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement
Czechia, Italy79 participantsStarted 2014-12
Plain-language summary
This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed diagnosis of diffuse large B-cell lymphoma
✓. CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis (concomitant to extra-CNS disease) or relapse after conventional chemo(-immuno)therapy
✓. Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable when stereotactic biopsy is formally contraindicated or when the disease has been previously histologically documented in other areas and the CNS localization is concomitant with a diffuse progression of systemic disease.
✓. No previous treatment with high-dose methotrexate-based chemotherapy and/or brain irradiation. One-two courses of R-CHOP combination as upfront therapy are admitted in patients with large amount and/or extensive extra-CNS disease that could condition prognosis in an early phase of treatment. Local investigator decides if initial R-CHOP is needed based on patient's conditions
✓. Age 18-70 years
✓. ECOG performance status 0-3
✓. Adequate bone marrow (Platelets count ≥100.000/mm3, hemoglobin ≥9 g/dL, neutrophils count≥1.500/mm3), renal (creatinine clearance ≥60 mL/min), cardiac (LVEF ≥50%), and hepatic function (total serum bilirubine ≤3 mg/dL, AST/ALT and GGT ≤2.5 per upper normal limit value), unless the abnormality is due to lymphoma infiltration
✓. Absence of HIV infection and of detectable HCV-RNA and/or HBsAg and/or HBV-DNA
Exclusion criteria
✕. Other lymphoma categories other than diffuse large B-cell lymphoma. In particular, patients with primary mediastinal lymphoma, intravascular large B-cell lymphoma or leg-type large B-cell lymphoma are excluded.
What they're measuring
1
1 Year Progression Free Survival (PFS)
Timeframe: From study entry until 1 year after
Trial details
NCT IDNCT02329080
SponsorInternational Extranodal Lymphoma Study Group (IELSG)
✕. Patients with positive flow cytometry examination of the CSF, but negative results in CSF conventional cytology, and without any other evidence of CNS disease.
✕. Patients with exclusive CNS disease at presentation (primary CNS lymphoma) are excluded
✕. Previous treatment with support of autologous or allogeneic stem cells/bone marrow transplantation.
✕. Symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
✕. Any other serious medical condition which could impair the ability of the patient to participate in the trial.