RECRUITING

A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-11
Study Completion:2027-12-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06736613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed Informed Consent.
  2. * Ability and willingness to comply with the requirements of the study protocol.
  3. * Age ≥ 18 years old.
  4. * 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:
  5. 1. Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4.
  6. 2. Stage III/IV High Grade B-cell lymphoma (HGBCL) with MYC, BCL2, and/or BCL6 translocations
  7. 3. Primary DLBCL of Breast
  8. 4. Primary DLBCL of Testis
  9. 5. Primary Cutaneous DLBCL, Leg Type
  10. 6. Intravascular Large B-cell Lymphoma
  11. 7. Stage III/IV HIV-associated DLBCL
  12. 8. Double expressor DLBCL (co-expression of MYC ≥ 40% and BCL2 ≥ 50% without translocations) with a CNS IPI score ≥ 3
  13. 9. DLBCL with the following extranodal involvement AND CNS IPI score ≥ 3
  14. * Transformed DLBCL from any indolent B-cell lymphoma is permitted (as long as there is no prior history of CNS involvement).
  15. * Planned to receive standard chemoimmunotherapy.
  16. * 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.
  17. * 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.
  18. * ECOG performance status of 0 to 2.
  1. * 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.
  2. * 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.
  3. * 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).
  4. * 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.
  5. * Psychiatric illness or social situations that would limit the patient's ability to tolerate and/or comply with study requirements.

Contacts and Locations

Study Contact

Jennifer Lue, MD
CONTACT
646-608-4160
luej@mskcc.org
Ariela Noy, MD
CONTACT
646-608-3727
noya@MSKCC.ORG

Principal Investigator

Jennifer Lue, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jennifer Lue, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2027-12-11

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2027-12-11

Terms related to this study

Keywords Provided by Researchers

  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Stage III High Grade B-Cell Lymphoma
  • Stage IV High Grade B-Cell Lymphoma
  • DLBCL - Diffuse Large B Cell Lymphoma
  • Intravascular Large B-Cell Lymphoma
  • Diffuse Large B Cell Lymphoma of Breast
  • Diffuse Large B Cell Lymphoma of Testis
  • HIV-associated Diffuse Large B Cell Lymphoma
  • Double expressor DLBCL
  • Circulating Tumor DNA
  • ctDNA
  • Memorial Sloan Kettering Cancer Center
  • 24-336

Additional Relevant MeSH Terms

  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Stage III High Grade B-Cell Lymphoma
  • Stage IV High Grade B-Cell Lymphoma
  • DLBCL - Diffuse Large B Cell Lymphoma
  • Intravascular Large B-Cell Lymphoma
  • Diffuse Large B Cell Lymphoma of Breast
  • Diffuse Large B Cell Lymphoma of Testis
  • HIV-associated Diffuse Large B Cell Lymphoma
  • Double Expressor DLBCL