Active — Not RecruitingPhase 3

OptiMATe: De-escalated Induction Treatment in Primary CNS Lymphoma

Germany331 participantsStarted 2021-06-28

Plain-language summary

This phase III study investigates if a de-escalated induction treatment in newly diagnosed primary CNS lymphoma is superior to the standard MATRix protocol in terms of event free survival.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system (PCNSL).
✓. Male or female patients aged 18-65 years irrespective of ECOG or 66-70 years with ECOG Performance Status ≤2.
✓. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
✓. Disease exclusively located in the CNS.
✓. At least one measurable lesion.
✓. Previously untreated patients (previous or ongoing steroid treatment admitted)
✓. Negative pregnancy test
✓. 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.

Exclusion criteria

✕. Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
✕. Systemic lymphoma manifestation (outside the CNS).
✕. Primary vitreoretinal lymphoma without manifestation in the brain parenchyma or spinal cord
✕. 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.
✕. Previous Non-Hodgkin lymphoma at any time.
✕. Inadequate renal function (clearance \< 60 ml/min).
✕. Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision
✕. Active hepatitis B or C disease.

What they're measuring

Event-free survival (EFS)

Timeframe: up to 24 months after end of treatment

Trial details

NCT IDNCT04931368

SponsorKlinikum Stuttgart

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

View on ClinicalTrials.gov More Primary Central Nervous System Lymphoma trials