High-dose chemotherapy and autologous stem cell transplantion or consolidating conventional chemotherapy in primary CNS lymphoma – randomized phase III trial - MATRix / IELSG43
- Conditions
- C83.3Diffuse large B-cell lymphoma
- Registration Number
- DRKS00005503
- Lead Sponsor
- Klinik für Haematologie, Onkologie und Palliativmedizin, Stuttgart Cancer Center / Tumorzentrum Eva Mayr-StihlKlinikum Stuttgart
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 342
INCLUSION CRITERIA
1.Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma
2.Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status = 2)
3.3.Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
4.Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
5.Disease exclusively localized in the CNS, CSF or cranial nerves
6.At least one measurable lesion
7.Previously untreated patients (previous or ongoing steroid treatment admitted)
8.Sexually active patients of childbearing potential who agree to apply adequate contraceptive measures during study participation
9.Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease
ADDITIONAL RANDOMIZATION CRITERIA
1.Sufficient stem cell harvest (= 3 x 106 CD34+ cells/kg of body weight)
2.Complete remission, unconfirmed complete remission or partial remission
3.Central pathology results confirming local results
4. Exclusion criterion no. 6 not applicable for re-check for randomization
EXCLUSION CRITERIA
1.Congenital or acquired immunodeficiency
2.Systemic lymphoma manifestation (outside the CNS)
3.Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord
4.Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years
5.Previous Non-Hodgkin lymphoma at any time
6.Only applicable for patient inclusion (registration) not applicable for recheck
for randomization. Inadequate bone marrow (platelet count decreased =CTC grade 1, anemia =CTC grade 1, neutrophil count decreased =CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased =CTC grade 2), or hepatic function (blood bilirubin increased =CTC grade 2, alanine aminotransferase increased =CTC grade 2, aspartate aminotransferase increased =CTC grade 2 or gamma-GT increased =CTC grade 2)
7.HBsAg, anti-HBc and HCV positivity
8.HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
9.Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
10.Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
11.Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
12.Third space fluid accumulation >500 ml
13.Hypersensitivity to study treatment or any component of the formulation
14.Taking any medications likely to cause interactions with the study medication
15.Known or persistent abuse of medication, drugs or alcohol
16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
18.Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
19.Concurrent (or planned) pregnancy or lactation
20.Fertile patients refusing to use safe contraceptive methods during the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint:<br>Progression-free survival (PFS) time from randomization until progression, relapse, or death from any cause.<br><br>Progression-free survival PFS:<br>Response Assessment III at the end of study treatment (EOT) visit and<br>every imaging diagnostic assessments during follow-up period: <br>during year 1-2: every 3 month<br>from year 3-5: every 6 month<br>or imaging in case of clinical suspicion of disease progression or relapse
- Secondary Outcome Measures
Name Time Method