Status:
UNKNOWN
ctDNA and Metabolites in CSF as Early Biomarkers of Secondary CNS Involvement in Diffuse Large B-cell Lymphoma
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Diffuse Large B Cell Lymphoma
Central Nervous System Metastasis
Eligibility:
All Genders
18+ years
Brief Summary
The study is a prospective clinical study which investigates the use of new diagnostic methods to localize aggressive lymphoma involving the central nervous system(CNS). By measuring cell-free tumor D...
Detailed Description
Diffuse Large B-cell Lymphoma is a malignant, aggressive cancer representing 40% of Non-Hodgkin Lymphomas globally. The risk of relapse after primary treatment is approximately 30% of which up to 10 %...
Eligibility Criteria
Inclusion
- Pilot Study:
- Inclusion criteria:
- Verified or suspected primary CNS lymphoma or verified or suspected DLBCL relapsed in the CNS
- Treatment of the relapse not initiated (except pretreatment with corticosteroids)
- Age ≥ 18 years
- Patient must consent to genetic and metabolomic analysis of their cancer
- Written informed consent
- Exclusion criteria:
- Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated
- Other contraindications to lumbar puncture according to local guidelines
- Other previous or current hematological malignancy
- Prior treatment for CNS disease (except CNS prophylaxis in first line lymphoma treatment)
- Known CNS autoimmune or inflammatory disease
- Known HIV infection
- Patient is currently receiving treatment for DLBCL
- Study 1
- Inclusion criteria:
- Previously diagnosed histologically documented DLBCL
- Verified relapsed DLBCL
- ≥ 1 prior DLBCL treatments
- Treatment of the relapse not initiated (except pretreatment with corticosteroids)
- Being able to undergo standard assessment ( eg, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET), MRI of the neuroaxis and bone marrow biopsy)
- Tumor biopsy and/or bone-marrow biopsy used for diagnosis available
- Age ≥ 18 years
- ECOG performance status of 0, 1 or 2
- Life expectancy ≥ 12 weeks
- Patient must consent to permit genetic and metabolomic analysis of their cancer
- Patient must consent to permit access to records in order to ascertain progression or relapse of their cancer
- Written informed consent
- Exclusion criteria:
- Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated
- Other contraindications to lumbar puncture according to local guidelines
- Other previous or current hematological malignancy
- Previous or current primary CNS malignancy including know DLBCL relapse to the CNS
- Prior treatment for CNS disease (except CNS prophylaxis in first line lymphoma treatment)
- Known CNS autoimmune or inflammatory disease
- Known HIV infection
- Patient is currently receiving treatment for DLBCL (except pretreatment with corticosteroids)
- Study 2
- Inclusion criteria:
- A newly diagnosed and histologically verified DLBCL
- No prior DLBCL treatments
- Anti-lymphoma treatment not initiated (except pretreatment with corticosteroids)
- CNS-IPI \>/= 3
- Being able to undergo standard assessment ( eg, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET), MRI of the neuroaxis and bone marrow biopsy)
- Tumor biopsy and/or bone-marrow biopsy used for diagnosis available
- Age ≥ 18 years
- ECOG performance status of 0, 1 or 2
- Life expectancy \>/= 12 weeks
- Patient must consent to permit genetic analysis of their cancer
- Patient must consent to permit access to records in order to ascertain progression or relapse of their cancer
- Written informed consent
- Exclusion criteria:
- Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated
- Other contraindications to lumbar puncture according to local guidelines
- Other previous or current hematological malignancy
- Previous or current primary CNS malignancy including primary CNS lymphoma
- Prior treatment for CNS disease
- Known CNS autoimmune or inflammatory disease
- Known HIV infection
- Patient is currently receiving treatment for DLBCL (except pretreatment with corticosteroids)
Exclusion
Key Trial Info
Start Date :
August 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04112238
Start Date
August 29 2019
End Date
June 1 2023
Last Update
March 22 2022
Active Locations (1)
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1
Herlev Hopital
Herlev, Capital Region, Denmark, 2730