What is this trial studying for primary central nervous system lymphoma?

This trial is studying two treatment approaches for elderly patients with primary central nervous system lymphoma to see which better improves survival, remission, quality of life, and reduces treatment side effects. The University Hospital Freiburg is leading this research to improve options for this vulnerable group.

Who may be eligible for this primary central nervous system lymphoma clinical trial?

Adults aged 65 years or older diagnosed with primary diffuse large B-cell lymphoma limited to the central nervous system may be eligible. Both men and women can participate if they meet health and treatment eligibility, including the ability to receive high-dose chemotherapy and stem cell transplantation. Please review eligibility criteria for more details.

Is there any cost to participate in this primary central nervous system lymphoma clinical trial?

Study-related care, including the study drugs, procedures, and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect regular visits for treatment and monitoring during the study.

Actively Recruiting

Phase 3

Age: 65Years +

All Genders

ID06830421

Comparing High-dose Chemotherapy with Stem Cell Transplant to Standard Immunochemotherapy for Elderly Patients with Primary Central Nervous System Lymphoma A Randomized Phase III Study

Led by University Hospital Freiburg · Updated on 2025-02-17

340

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Primary diffuse large B-cell lymphoma of the central nervous system PCNSL mainly affects patients aged 60 and above, who often face a poor outlook. This trial compares two treatment options for elderly patients 65 years and older with newly diagnosed PCNSL who are eligible for high-dose methotrexate HD-MTX therapy. The study aims to determine which treatment approach improves survival, response rates, quality of life, and reduces treatment-related side effects in this vulnerable group. One treatment uses the R-MP regimen, which includes rituximab, HD-MTX, and procarbazine given in cycles followed by maintenance procarbazine therapy. The other approach involves a shorter induction treatment with rituximab, HD-MTX, and cytarabine, followed by age-adjusted high-dose chemotherapy and autologous stem cell transplantation HCT-ASCT. Patients receive either three cycles of R-MP plus procarbazine maintenance or two cycles of R-MTXAraC followed by the stem cell transplant procedure with additional chemotherapy drugs. Participants will undergo regular assessments including remission status evaluations after early and later treatment phases, quality of life questionnaires, and long-term monitoring for up to six years. The primary outcome is progression-free survival, with secondary outcomes including overall survival, event-free survival, and quality of life measures. Researchers will also perform geriatric assessments to help define eligibility for the transplant procedure and monitor treatment safety and effectiveness throughout the study period.

CONDITIONS

Brief Title

Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients

Who Can Participate

Age: 65Years +

All Genders

Eligibility Criteria

You may qualify if you...

Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system.
Age over 70 years, or age 65 to 70 years if not eligible for more intensive treatment.
Diagnosis confirmed by local pathologist through biopsy, cerebrospinal fluid cytology, or vitrectomy.
Disease located only in the central nervous system.
At least one measurable lesion.
Eastern Cooperative Oncology Group performance status of 2 or less; higher scores accepted if due to lymphoma symptoms.
Possible eligibility for high-dose chemotherapy and autologous stem cell transplantation as judged by the treating physician.
Written informed consent obtained from patient or authorized representative.
No disease progression after pre-phase treatment and meeting criteria for transplant eligibility.

You will not qualify if you...

Congenital or acquired immune deficiencies including HIV infection and previous organ transplantation.
Lymphoma outside the central nervous system.
Primary vitreoretinal or leptomeningeal lymphoma without brain or spinal cord involvement.
Previous or current cancers except for cured carcinoma in situ or cancer free for at least 5 years.
Previous systemic Non-Hodgkin lymphoma.
Inadequate kidney, bone marrow, heart, lung, or liver function.
Active hepatitis B or C disease.
Participation in other interventional clinical trials with study drugs within 30 days before this study.
Excessive fluid accumulation (>500 ml).
Allergies to study treatments.
Current use of medications that may interact with study drugs.
Known or ongoing substance abuse.
Active COVID-19 infection or non-compliance with COVID-19 measures.
Lack of legal capacity to consent without representative.
Previous participation in this trial.
Employment or dependency relationship with the sponsor or investigator.
Conditions that may prevent compliance with the study protocol.
Fertile patients refusing to use contraception during the study.

Research Team

Elisabeth Schorb, MD

Gerald Illerhaus, MD

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Comparing High-dose Chemotherapy with Stem Cell Transplant to Standard Immunochemotherapy for Elderly Patients with Primary Central Nervous System Lymphoma A Randomized Phase III Study

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria