A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma
Cerebral Spinal Fluid Circulating Tumor DNA (ctDNA) Analysis in Patients With Aggressive B-cell Lymphoma Receiving Front Line Therapy and at High Risk for Central Nervous System Relapse
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with B-cell lymphoma who have a high risk of the cancer coming back in the brain or spinal cord. It looks for tumor DNA in the fluid around the brain and spinal cord, even when standard tests show no cancer there. It also compares how often cancer comes back in these areas in people with and without tumor DNA in this fluid.
The purpose of this study is to find out how many people with B-cell lymphoma who are at high risk for central nervous system/CNS relapse test positive for cerebral spinal fluid/CSF ctDNA but test negative for CNS involvement using standard tests. The study will also look at how often CNS relapse happens in people with and without detected CSF ctDNA.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, sign a consent form, and be able and willing to follow study rules.
- Have one of the listed types of B-cell lymphoma that has a high risk of coming back in the brain or spinal cord. Some types also need certain risk scores, stages, gene changes, or affected body areas.
- Lymphoma that changed from a slow-growing B-cell lymphoma into diffuse large B-cell lymphoma may qualify, if it has never involved the brain or spinal cord.
- Plan to receive standard chemotherapy with treatment that helps the immune system fight cancer.
- Be able to safely have a spinal tap, a test that takes fluid from around the spinal cord.
- Have had no treatment that travels through the body for the aggressive B-cell lymphoma before joining. Past treatment for slow-growing lymphoma is allowed.
- Steroids are allowed for up to 7 days, with the dose lowered to no more than 20 mg of prednisone daily, or an equal dose of another steroid, by the first day of anthracycline chemotherapy. The study leader may approve exceptions.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
Who can't join
- Treatment that travels through the body for another cancer within the past 2 years, except for slow-growing B-cell lymphoma. Surgery or radiation aimed at curing cancer in one area is allowed.
- Another active cancer, except certain skin cancers, prostate cancer that has not spread, or other cancers limited to one area, such as early cancers of the cervix, breast, or bladder.
- An illness that is not controlled and that the study doctor believes would prevent cancer treatment aimed at a cure.
- A known active infection when joining, except a fungal nail infection. A major infection needing IV antibiotics or a hospital stay in the 2 weeks before treatment also rules you out.
- A mental health condition or life situation that would make it hard to handle treatment or follow study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Signed Informed Consent. * Ability and willingness to comply with the requirements of the study protocol. * Age ≥ 18 years old. * Diagnosis of the following histologies according to the 2016 WHO Classification for Mature Lymphoid Neoplasms81 along with a specific high-risk criteria for CNS relapse if indicated as certain diagnoses in of themselves are high-risk alone: 1. Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4. 2. Stage III/IV High Grade B-cell lymphoma (HGBCL) with MYC, BCL2, and/or BCL6 translocations 3. Primary DLBCL of Breast 4. Primary DLBCL of Testis 5. Primary Cutaneous DLBCL, Leg Type 6. Intravascular Large B-cell Lymphoma 7. Stage III/IV HIV-associated DLBCL 8. Double expressor DLBCL (co-expression of MYC ≥ 40% and BCL2 ≥ 50% without translocations) with a CNS IPI score ≥ 3 9. DLBCL with the following extranodal involvement AND CNS IPI score ≥ 3: i. Adrenal ii. Breast iii. Bone Marrow with pathological overt morphological involvement iv. Epidural/Paraspinal v. Nasal/parasinus with local invasion such as bone destruction vi. Renal viii. Uterine ix. Testis xi. Skull involvement without direct invasion into CNS/brain parenchyma * Transformed DLBCL from any indolent B-cell lymphoma is permitted (as long as there is no prior history of CNS involvement). * Planned to receive standard chemoimmunotherapy. * Patient is able to undergo lumbar puncture without any contraindications which include but are not limited to altered mental status, increased intracranial pressure due to any CNS lesion (mass, abscess), overlying skin infection at the site of LP, inability to safely access CSF due to lymphomatous involvement (i.e. epidural mass), or inability to hold antiplatelet or anticoagulation safely for the procedure to be performed. * No systemic therapy prior to study enrollment for an aggressive B-cell lymphoma is permitted. Treatment for a history of indolent lymphoma is permitted. Systemic corticosteroids are permitted (must be ≤7 days and tapered down to prednisone ≤ 20 mg oral/day or steroid equivalent by first day of anthracycline treatment). Clinical exceptions in regards to steroid management can be made after discussion with PI. * ECOG performance status of 0 to 2. Exclusion Criteria: * Active systemic therapy for another malignancy (other than indolent B-cell lymphoma) within 2 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 2 years of treatment is permitted. * Active concurrent malignancy with the exception of basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder. * Any uncontrolled illness that in the opinion of the investigator would preclude administration of curative intent chemoimmunotherapy (e.g. significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction). * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to Cycle 1, Day 1. * Psychiatric illness or social situations that would limit the patient's ability to tolerate and/or comply with study requirements.
Study sites (7)
NJ
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Jennifer Lue, MD · Study contact · 646-608-4160More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Jennifer Lue, MD · Study contact · 646-608-4160More trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Jennifer Lue, MD · Study contact · 646-608-4160More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, NY 11725Jennifer Lue, MD · Study contact · 646-608-4160More trials in Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, NY 10604Jennifer Lue, MD · Study contact · 646-608-4160More trials in Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) · New York, NY 10065Jennifer Lue, MD · Study contact · 646-608-4160More trials in New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) · Rockville Centre, NY 11553Jennifer Lue, MD · Study contact · 646-608-4160More trials in Rockville Centre