CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)

NCT06755619 | Recruiting

• 2 other identifiers: 24020NLG-PCNSL-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

This is an international, prospective, multicenter trial with the aim of characterizing circulating tumor DNA (ctDNA) for early response assessment in PCNSL patients treated with standard of care (SOC) 1st line therapy with a curative intent (Figure 1). Secondary endpoints are to assess the clinical characteristics, health-related quality of life (HRQoL), neurological status, and outcome of newly diagnosed primary central nervous system lymphoma (PCNSL) patients in the Nordic countries. Patients eligible for a curative intent SOC 1st line therapy, such as MATRix + high-dose chemotherapy and autologous stem cell transplantation (HDCT/ASCT), are eligible for the trial. Diagnostic tumor tissue, cerebrospinal fluid (CSF), and plasma samples are collected for ctDNA and translational analyses with the aim describing new prognostic and predictive biomarkers. Treatment responses are assessed with the International PCNSL Collaborative Group (IPCG) response criteria, and diagnostic and response assessment magnetic resonance imaging (MRI) images are centrally analyzed in order to describe new prognostic and predictive markers.

Conditions

Primary Central Nervous System (CNS) Lymphoma

Keywords

PCNSL; ctDNA

Outcome Measures

Primary Outcomes (1)

• ctDNA

  Predictive value and sensitivity of CSF and plasma ctDNA

  6 months from initiation of 1st line therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma

You may qualify if:

• Age 18-70 years at diagnosis
• Histologically or cytologically verified diffuse large B-cell lymphoma (DLBCL) of the central nervous system (CNS)
• No prior treatment for PCNSL (pre-treatment corticosteroids are allowed and recommended)
• Fit for standard of care (SOC) 1st line therapy with a curative intent such as full-dose MATRix, according to local policy
• Able to give voluntary written informed consent
• If the patient is temporarily incapacitated to give the voluntary written informed consent, due to PCNSL, the informed consent can be obtained from a legally acceptable representative, according to the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Guideline for Good Clinical Practice (ICH-GCP) guidelines

You may not qualify if:

• Lymphoma outside the CNS
• History of prior hematological malignancy e.g. low grade B-cell lymphoma
• Psychiatric illness or condition, other than PCNSL, which could interfere with the ability to understand the requirements of the study

Sponsors & Collaborators

• Nordic Lymphoma Group: lead

Study Sites (5)

Helsinki University Hospital

Helsinki, Finland

NOT YET RECRUITING

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Spinal fluid, peripheral blood, tumor tissue

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Marjukka Pollari, MD, PhD

CONTACT

+358 3 311 611; marjukka.pollari@pirha.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2038
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

FI (5)