B-cell Non-Hodgkin LymphomaNCT02633111
DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
An observational study of B-cell Non-Hodgkin Lymphoma and Aggressive, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma, Aggressive
- What is being tested?
- collected at pre-treatment tumor biopsy, Peripheral blood tests and PET/CT
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2015to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Who may be able to join
- 18 years of age at time of signing informed consent
- Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma
- De novo diffuse large B-cell lymphoma (including all subtypes such as primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma). According to the 2008 WHO Classification of Hematopoietic and Lymphoid Tumors. These would include double or triple-hit diffuse large B-cell lymphomas with MYC/BCL2 and/or BCL6 gene rearrangements. These cases may be classified as high grade B-cell lymphomas according to the 2017 revision of the WHO Classification of Hematopoietic and Lymphoid Tumors.
- Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
- Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
- Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.
Who cannot join
- Patients receiving 2nd or greater line of therapy.
- Stage I or II disease.
- Primary mediastinal B-cell lymphoma.
- Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
Harrison, New York, 10604
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Md Anderson Cancer Center
Houston, Texas, 77030
University of Miami
Miami, Florida
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Mayo Clinic
Rochester, Minnesota, 55902
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.
- Conditions
- B-cell Non-Hodgkin Lymphoma, Aggressive
- Being tested
- collected at pre-treatment tumor biopsy, Peripheral blood tests, PET/CT
- Keywords
- DNA Sequencing, 15-180
- Medical subject headings
- Lymphoma, B-Cell, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collected at pre-treatment tumor biopsyOther
to identify the tumor-specific clonotype
Peripheral blood testsOther
for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).
PET/CTDevice
at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)
| Study group | Role | What they receive |
|---|---|---|
| Patients with aggressive B-cell Non-Hodgkin lymphoma | This is a non-therapeutic protocol aimed to assess the ability of Adaptive clonoSEQ® MRD assay to detect clinical relapse in DLBCLwhen compared to conventional approaches for detecting relapse such as patient-reported symptoms, clinical exams, and CT scans. Receives: Other: collected at pre-treatment tumor biopsy; Other: Peripheral blood tests; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD assay to predict clinical relapse
using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, M.D. Anderson Cancer Center, University of Pennsylvania, University of Miami
- Responsible party
- Sponsor
- Investigators
- Anita Kumar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633111
- Sponsor's protocol ID
- 15-180
- Status last verified
- Nov 2026
- First submitted
- 15 Dec 2015
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
- ClinicalTrials.gov ID
- NCT02633111
- Acronym / sponsor ID
- 15-180
- Conditions
- B-cell Non-Hodgkin Lymphoma, Aggressive
- Keywords
- DNA Sequencing, 15-180
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Mayo Clinic, M.D. Anderson Cancer Center, University of Pennsylvania, University of Miami
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aggressive B-cell Non-Hodgkin lymphoma | – | Other: collected at pre-treatment tumor biopsy, Other: Peripheral blood tests, Device: PET/CTThis is a non-therapeutic protocol aimed to assess the ability of Adaptive clonoSEQ® MRD assay to detect clinical relapse in DLBCLwhen compared to conventional approaches for detecting relapse such as patient-reported symptoms, clinical exams, and CT scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Key inclusion criteria (6 listed)
- 18 years of age at time of signing informed consent
- Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma
- Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
- Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
- Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.
Key exclusion criteria (4 listed)
- Patients receiving 2nd or greater line of therapy.
- Stage I or II disease.
- Primary mediastinal B-cell lymphoma.
- Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collected at pre-treatment tumor biopsyto identify the tumor-specific clonotype | Other | Patients with aggressive B-cell Non-Hodgkin lymphoma |
| Peripheral blood testsfor MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month). | Other | Patients with aggressive B-cell Non-Hodgkin lymphoma |
| PET/CTat 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month) | Device | Patients with aggressive B-cell Non-Hodgkin lymphoma |
Primary outcome
MRD assay to predict clinical relapse
Time frame: 2 years
using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Kumar, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Non-Hodgkin Lymphoma and Aggressive, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD assay to predict clinical relapse (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.