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Lymphoma, Large B-Cell, DiffuseNCT04237168

Non-invasive Tumor Immunoglobulin Gene Next Generation Sequencing (IgNGS) in Diffuse Large B Cell Lymphoma (DLBCL)

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will evaluate IgNGS at different time points in newly diagnosed DLBCL patients homogeneously treated (RCHOP) to address its correlation with conventional techniques (i.e., positron emission tomography/computed tomography imaging (PET/CT) and outcome. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
IgNGS from circulating tumor DNA
How many people
30 participants
Where
1 siteSpain
Study dates
Jan 2020to Jul 2022
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: newly DLBCL patients (diagnosed and treated in "Hospital de la Santa Creu i Sant Pau")

Who may be able to join

None listed.

Who cannot join

  • Primary mediastinal DLBCL.
  • Transformed DLBCL
  • Patients HIV+
  • Central Nervous System (CNS) DLBCL
  • All other DLBCL not included under "NOS" classification, according to WHO 2016 (except those specifically indicated in "inclusion criteria").

Trial locations and contacts

1 site in 1 country.

Javier Briones, PhD contact

+34935565649

jbriones@santpau.cat

Anna Monter-Rovira, MD contact

amonter@santpau.cat

Spain1 site

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Javier Briones, PhD, jbriones@santpau.cat

    Anna Monter-Rovira, MD, amonter@santpau.cat

Other trials in Spain

About this study

Official title: Non-invasive Tumor Immunoglobulin Gene Next Generation Sequencing (IgNGS) in Diffuse Large B Cell Lymphoma (DLBCL): Prognostic Implications and Assessment of Tumor Response

This study will evaluate IgNGS at different time points in newly diagnosed DLBCL patients homogeneously treated (RCHOP) to address its correlation with conventional techniques (i.e., positron emission tomography/computed tomography imaging (PET/CT) and outcome.

Read the detailed description

In B-cell malignancies, every lymphocyte clone expresses a unique antigen receptor structure, therefore immunoglobulin gene rearrangements (the sequence of nucleotides at the V(D)J recombination site) serves as a specific marker for each clone. Methods of analysis have changed over time to improve the sensitivity and to allow its application in clinical settings.

Diffuse Large B-cell lymphoma (DLBCL) displays molecular heterogeneity. In this context, IgNGS allows for detection of tumor clonotype from plasma (ctDNA) (Liquid Biopsy-LB) of DLBCL patients with high sensitivity and specificity. ctDNA can be tracked with this methodology in the vast majority (>90%) of patients, in contrast to NGS-methods based on genotyping for specific DLBCL mutations, which have overall low frequency. Furthermore, most newly discovered neoantigens in lymphoma derive from immunoglobulin variable sequences, supporting the relevance of the analysis of this particular region in contrast to the use of specific B-cell mutations. Importantly, preliminary studies on clonotype detection by IgNGS at the end of treatment correlate with outcome (poorer progression-free survival) and the persistence or reemergence of the tumor clonotype by ctDNA studies may anticipate the clinical relapse. We propose to evaluate IgNGS at different time points in newly diagnosed DLBCL patients treated with RCHOP to address its correlation with conventional techniques (i.e., PET/CT imaging) and outcome.

Being tested
IgNGS from circulating tumor DNA
Keywords
Diffuse large B cell lymphoma, immunoglobulin gene next generation sequencing, liquid biopsy
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IgNGS from circulating tumor DNADiagnostic test

    3 longitudinal plasma samples will be evaluated at three different time points per patient: 0 (pre-treatment), end of treatment, and at 6 months after treatment.

Study groups in NCT04237168
Study groupRoleWhat they receive
DLBCL patientsnewly diagnosed DLBCL (de novo, all ages) patients treated with RCHOP (first-line treatment regimen)
Receives: Diagnostic Test: IgNGS from circulating tumor DNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association between ctDNA level and clinical response at the end of treatment

    Correlation between ctDNA level (in nanograms) and clinical response per PET/CT at the end of treatment (responses will be defined according to International Working Group consensus response evaluation criteria in lymphoma - IWGRECIL - 2017) will be assessed by means of Spearman correlation.

    Measured: 12-18 months

Secondary outcomes (2)

  1. Correlation between detection of tumor clonotype ctDNA and relapse

    The relationship between detection of tumor clonotype ctDNA (detection: yes/no, using a frequency threshold of 5%) and relapse (disease status will be assessed by PET/CT) will be measured by means of a logistic regression model. These analyses are explorative and will be done if possible.

    Measured: 18 months

  2. Impact of IgNGS at the end of treatment and 6 months after treatment on outcome (as measured by progression-free survival PFS)

    The relationship between impact of IgNGS (ctDNA level in nanograms, detection of tumor clonotype: yes/no, relative frequency of index sequences in %) with PFS will be assessed by means of a Proportional-hazards (PH) Cox regression model. These analyses are explorative and will be done if possible.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study startJan 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237168
Sponsor's protocol ID
IIBSP-LIN-2019-83
Status last verified
Jan 2020
First submitted
17 Jan 2020
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: relevant results will be published in scientific journals available to all researchers.

Publications

  • Herrera AF, Armand P. Minimal Residual Disease Assessment in Lymphoma: Methods and Applications. J Clin Oncol. 2017 Dec 1;35(34):3877-3887. doi: 10.1200/JCO.2017.74.5281. Epub 2017 Sep 21.

    PubMed 28933999

  • Scherer F, Kurtz DM, Newman AM, Stehr H, Craig AF, Esfahani MS, Lovejoy AF, Chabon JJ, Klass DM, Liu CL, Zhou L, Glover C, Visser BC, Poultsides GA, Advani RH, Maeda LS, Gupta NK, Levy R, Ohgami RS, Kunder CA, Diehn M, Alizadeh AA. Distinct biological subtypes and patterns of genome evolution in lymphoma revealed by circulating tumor DNA. Sci Transl Med. 2016 Nov 9;8(364):364ra155. doi: 10.1126/scitranslmed.aai8545.

    PubMed 27831904

  • Scherer F, Kurtz DM, Diehn M, Alizadeh AA. High-throughput sequencing for noninvasive disease detection in hematologic malignancies. Blood. 2017 Jul 27;130(4):440-452. doi: 10.1182/blood-2017-03-735639. Epub 2017 Jun 9.

    PubMed 28600337

  • Kurtz DM, Green MR, Bratman SV, Scherer F, Liu CL, Kunder CA, Takahashi K, Glover C, Keane C, Kihira S, Visser B, Callahan J, Kong KA, Faham M, Corbelli KS, Miklos D, Advani RH, Levy R, Hicks RJ, Hertzberg M, Ohgami RS, Gandhi MK, Diehn M, Alizadeh AA. Noninvasive monitoring of diffuse large B-cell lymphoma by immunoglobulin high-throughput sequencing. Blood. 2015 Jun 11;125(24):3679-87. doi: 10.1182/blood-2015-03-635169. Epub 2015 Apr 17.

    PubMed 25887775

  • Roschewski M, Dunleavy K, Pittaluga S, Moorhead M, Pepin F, Kong K, Shovlin M, Jaffe ES, Staudt LM, Lai C, Steinberg SM, Chen CC, Zheng J, Willis TD, Faham M, Wilson WH. Circulating tumour DNA and CT monitoring in patients with untreated diffuse large B-cell lymphoma: a correlative biomarker study. Lancet Oncol. 2015 May;16(5):541-9. doi: 10.1016/S1470-2045(15)70106-3. Epub 2015 Apr 1.

    PubMed 25842160

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Javier Briones, PhD (+34935565649, jbriones@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between ctDNA level and clinical response at the end of treatment (time frame: 12-18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237168, which also lists 5 linked publications.

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 29 Jan 2020.

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