RECRUITING

ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL

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Conditions

LymphomaLymphoma, B-CellDiffuse Large B Cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedHigh-grade B-cell Lymphomacirculating tumor DNAmeasurable residual disease

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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 1) determine whether it is feasible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL), and 2) evaluate the outcomes of participants with undetectable ctDNA in the middle of treatment who receive a shortened course of chemotherapy. There are no investigational drug agents to be administered in this study. The investigational assay, phased variant enrichment and detection sequencing (PhasED-seq) will be used to guide de-escalation of standard-of-care therapy for newly diagnosed DLBCL. The PhasED-seq assay has not yet been approved by the Food and Drug Administration (FDA).

Official Title

Sequencing-guided cHemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With Circulating Tumor DNA: SHORTEN-ctDNA

Quick Facts

Study Start:2024-12-30
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06693830

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. 1. Patients with newly diagnosed, histologically confirmed CD20+ DLBCL
  2. 2. Age 18 years or older at time of screening
  3. 3. Subject/legal representative willing and able to provide written informed consent
  4. 4. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation
  5. 5. Organ function as assessed by laboratory and cardiac function testing and Eastern Cooperative Oncology Group (ECOG) performance status in appropriate range for receipt of R-CHOP or R-pola-CHP at standard dose as per treating physician
  1. 1. Previous treatment for diffuse large B-cell lymphoma, except as outlined below a. Up to 14 days of corticosteroids for the relief of lymphoma-related symptoms b. A single dose of vincristine c. One cycle of R-chemotherapy (including R-CHOP, R-pola-CHP, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab \[DA-EPOCH-R) that has not started more than 28 days prior to enrollment d. A single dose of intrathecal chemotherapy e. Radiation therapy for the treatment or prevention of spinal cord compression that has not started more than 28 days prior to enrollment.
  2. 2. Simultaneous participation in other treatment clinical protocol
  3. 3. Planned anti-lymphoma therapies beyond R-CHOP or R-pola-CHP
  4. 1. Consolidative radiation to any baseline sites of disease
  5. 2. Planned high-dose intravenous methotrexate for central nervous system (CNS) lymphoma prophylaxis (both mid-cycle and EOT excluded)
  6. 4. Transformed indolent lymphoma (including follicular lymphoma, marginal zone lymphoma, or lymphoplasmacytic lymphoma) or grade IIIB follicular lymphoma
  7. 5. Known central nervous system (CNS) involvement by lymphoma. R-CHOP and R-pola- CHP are insufficient to treat CNS disease.
  8. 6. Any disease characteristics that would make R-CHOP or R-pola-CHP without radiation insufficient therapy at the discretion of the treating physician
  9. 7. Richter transformation of chronic lymphocytic leukemia
  10. 8. Pregnancy and/or nursing period. R-CHOP and R-pola-CHP may cause fetal harm or birth defects, and effects of exposure in the breastfed infant are unknown.
  11. 1. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "childbearing potential"
  12. 2. Women of childbearing potential are eligible if a negative serum or urine beta human chorionic gonadotropin pregnancy test is documented within 28 days of screening, and they must agree to us an effective contraception method during systemic treatment
  13. 3. Men who have partners of childbearing potential must agree to use an effective contraceptive method during systemic treatment
  14. 4. In addition to routine contraceptive methods, "acceptable contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  15. 9. Uncontrolled active systemic infection
  16. 1. Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be to take appropriate anti-viral prophylaxis
  17. 2. Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.
  18. 3. Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration.
  19. 9. Active second malignancy unless in remission and with life expectancy \> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma "in situ" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed.
  20. 10. Known hypersensitivity to any component of R-CHOP or R-pola-CHP

Contacts and Locations

Study Contact

Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Hua-Jay J Cherng, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Hua-Jay J Cherng, MD

  • Hua-Jay J Cherng, MD, PRINCIPAL_INVESTIGATOR, Columbia University

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 Date2024-12-30
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-12-30
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • circulating tumor DNA
  • measurable residual disease

Additional Relevant MeSH Terms

  • Lymphoma
  • Lymphoma, B-Cell
  • Diffuse Large B Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • High-grade B-cell Lymphoma