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DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633111
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : July 19, 2021
Sponsor:
Collaborators:
Mayo Clinic
M.D. Anderson Cancer Center
University of Pennsylvania
University of Miami
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
B-cell Non-Hodgkin Lymphoma Aggressive Other: collected at pre-treatment tumor biopsy Other: Peripheral blood tests Device: PET/CT

Study Design
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Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: collected at pre-treatment tumor biopsy
to identify the tumor-specific clonotype

Other: Peripheral blood tests
for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).

Device: PET/CT
at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633111


Locations
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United States, Florida
University of Miami
Miami, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States, 10604
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Mayo Clinic
M.D. Anderson Cancer Center
University of Pennsylvania
University of Miami
Investigators
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Principal Investigator: Anita Kumar, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02633111    
Other Study ID Numbers: 15-180
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
DNA Sequencing
15-180
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasm, Residual
Aggression
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Behavioral Symptoms
Neoplastic Processes