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New treatment option for Primary Central Nervous System Lymphoma
Official title Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients
ClinicalTrials.gov ID: NCT06830421
What this study is testing
What is R-MP and Procarbazine maintenance?
R-MP and Procarbazine maintenance is an investigational medicine, being studied as a potential treatment for primary central nervous system lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system.
- Age \> 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial).
- Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
- Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy.
- Disease exclusively located in the CNS.
You likely can't join if
- Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
- Systemic lymphoma manifestation (outside the CNS).
- Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord.
- Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for...
- Previous systemic Non-Hodgkin lymphoma at any time.
- Inadequate renal function (creatinine clearance \<60 ml/min).
See the full eligibility criteria
- Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system.
- Age \> 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial).
- Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
- Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy.
- Disease exclusively located in the CNS.
- At least 1 measurable lesion.
- Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) ≤ 2. ECOG PS \> 2 accepted if due to PCNSL symptoms.
- Patients possibly eligible for HCT-ASCT as judged by the treating physician.
- 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...
- Patients eligible for HCT-ASCT defined by the EBL score (at most one of the 3 following conditions may apply: ECOG PS \> 1, Barthel Index of activities of daily living (ADL) \ 3), improvement of PS after pre-phase...
- No evidence of disease progression after pre-phase treatment.
- Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.
- Systemic lymphoma manifestation (outside the CNS).
- Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord.
- Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for at least 5 years.
- Previous systemic Non-Hodgkin lymphoma at any time.
- Inadequate renal function (creatinine clearance \<60 ml/min).
- Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision.
- Active hepatitis B or C disease.
- Concurrent treatment with other experimental drugs or participation in an treatment clinical trial with administration of study medication within the last thirty days before the start of this study.
- Third space fluid accumulation \>500 ml.
- Hypersensitivity to study treatment or any component of the formulation.
- Taking any medications likely to cause interactions with the study medication.
- Known or persistent abuse of medication, drugs or alcohol.
- Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic.
- Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative.
- Previous participation in this trial.
- Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
- Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Fertile patients refusing to use safe contraceptive methods during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Stuttgart, Baden-Wurttemberg, Germany
- Aachen, Germany
- Augsburg, Germany
- Berlin, Germany
- Bielefeld, Germany
- Bochum, Germany
- Braunschweig, Germany
- Bremen, Germany
- Chemnitz, Germany
- Cologne, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Erlangen, Germany
- Essen, Germany
- Frankfurt, Germany
- Göttingen, Germany
- Halle, Germany
- Homburg, Germany
- Karlsruhe, Germany
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Baden-Wurttemberg, Germany; Stuttgart, Baden-Wurttemberg, Germany; Aachen, Germany; Augsburg, Germany; Berlin, Germany; Bielefeld, Germany and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.