Clinical Trial Details
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NCT03536039 : RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor
PhasePhase 2
AgesMin: 18 Years Max: 80 Years
Inclusion criteria

- Histological or cytological diagnosis of (D)LBCL

- Disease exclusively localized into the CNS (brain, meninges, cranial nerves, eyes
and/or spinal cord) both at first diagnosis and failure

- Progressive or recurrent disease

- Previous treatment with high-dose-methotrexate-based chemotherapy ± WBRT

- Presence of at least one target lesion, bidimensionally measurable

- Age 18 - 80 years

- ECOG performance status 0-3

- Adequate bone marrow (platelets >75.000/mm3, hemoglobin >8 g/dl, ANC >1.000/mm3),
renal (serum creatinine <2 times UNL and creatinine clearance =40 mL/min), cardiac
(VEF =50%), and hepatic (SGOT/SGPT <3 times UNL, bilirubin and alkaline phosphatase <2
times UNL) function.

- Given written informed consent prior to any study specific procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
without any prejudice. Informed consent signed by a patient's guardian is acceptable
if the patient is not able to decide inclusion in the study due to cognitive

5.3 Exclusion criteria

- Known HIV disease or other chronic immunodeficiency

- 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 concomitant extra-CNS disease at presentation or relapse

- 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

- Concurrent treatment with other antineoplastic drugs

- Therapy with PPI (Proton Pump Inhibitors, that may interfere with chromogranine
levels, see above). For gastroprotective therapy H2-blockers (i.e. ranitidine) are

- Pregnant and lactating female patients. Sexually active patients of child bearing
potential must implement adequate contraceptive measures during study participation.

- Previous or concurrent malignancies at other sites diagnosed or relapsed within the
last 3 years of follow-up. Patients with surgically cured in situ carcinomas and basal
cell carcinoma of the skin are allowed.

- Presence of any psycological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.
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