A study of Thiotepa, Ifosphamide, Etoposide and Rituximab for the treatment of relased or refractory primary central nervous system lymphoma.

Phase 1

• Conditions: Relapsed or refractory primary central neurvous system lymphoma.; MedDRA version: 20.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000227-24-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-26
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age = 16 years of age
• Histologically confirmed* CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) confined to the central nervous system
• Relapsed or refractory primary central nervous system lymphoma (PCNSL) according to the following definition :
o one or two prior chemotherapy regimen(s), of which at least one regimen contained high-dose methotrexate at a dose of >1g/m2.
• ECOG performance status 0,1 or 2 (or 3 if attributed to lymphoma)
• Adequate organ function
o Bone marrow: platelets >80 x109/L, neutrophils >1 x109/L, haemoglobin >80 g/L
o Hepatic: bilirubin <1.5 x upper limit of normal (ULN) (unless isolated unconjugated hyperbilirubinaemia attributable to Gilbert’s syndrome)
o Renal: eGFR =40ml/min (Cockcroft-Gault)
o Cardiorespiratory (as judged by the Local Investigator): clinically relevant cardiac or pulmonary function tests must be performed if there is a previous history of significant cardiac or pulmonary impairment
• Able to comply with the scanning requirements of the study
• Valid Informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

• Evidence of Systemic lymphoma
• Active infection requiring intravenous antimicrobials
• Chemotherapy for lymphoma within 4 weeks registration
• Whole-brain radiotherapy within 6 months of registration
• Relapse within 1 year of a Thiotepa-based autologous stem cell transplant
• Prior therapy with the R-IE (Rituximab – ifosphamide and etoposide) regimen with the last year
• Evidence of HIV or Hepatitis C infection
• Hepatitis B infection*
• Serum albumin <25g/l
• Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
• Competent pPatients and competent patients with partners of childbearing potential not willing to use effective contraception during and for 12 months after therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified