PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors

January 8, 2024 updated by: Grupo Argentino de Tratamiento de la Leucemia Aguda

Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)

Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.

A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Caba, Argentina
      • Caba, Argentina
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Fernando Warley, Dr.
      • Córdoba, Argentina
        • Recruiting
        • Clínica Universitaria Reina Fabiola
        • Contact:
          • Luciano Salvano, Dr.
      • Córdoba, Argentina
        • Recruiting
        • Hospital Privado de Cordoba
        • Contact:
          • Luciana Guanchiale, Dr.
    • Entre Ríos
      • Paraná, Entre Ríos, Argentina
        • Recruiting
        • Instituto Privado de Hematologia y Hemoterapia
        • Contact:
          • Florencia Negri Aranguren, Dr.
    • Provincia De Buenos Aires
      • La Plata, Provincia De Buenos Aires, Argentina
        • Recruiting
        • Hospital Italiano de La Plata
        • Contact:
          • Lorena Fiad, Dr.
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Recruiting
        • IDHEA Clínica Hematológica
        • Contact:
          • Amalia Cerutti, Dr.

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.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.

Description

Inclusion Criteria:

  • Patients > 17 years old with no upper age limit.
  • Histological diagnosis of DLBCL Stages I or II
  • Patients who have signed informed consent.

Exclusion Criteria:

  • Patients with elevated LDH (lactate dehydrogenase)
  • ECOG (Eastern Cooperative Oncology Group) > 2
  • Stage III or IV
  • Bulky mass (> 7.5 cm)
  • Central nervous system involvement
  • Testicular lymphoma
  • Breast involvement
  • Eyeball involvement
  • Primary mediastinal lymphoma
  • Cutaneous primary lymphoma
  • Diffuse large B-cell lymphoma of the leg
  • HIV positive patients
  • Platelet count <100,000 / mcl and total leukocyte count <3,000 / mcl
  • Marked impairment of ventricular function (FEy <50%)
  • Moderate / severe renal impairment defined by Cl. Cr. <50 ml / min
  • Severe liver disease: prothrombin rate <50% and / or bile level. total> 2.5 times normal value
  • Pregnant and breastfeeding
  • Previous or concomitant diagnosis of indolent lymphoma
  • Patients who have previously received chemotherapy and / or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with DLBCL limited stages and without risk factors
Patients with DLBCL in limited stages and without risk factors that will receive standard chemoimmunotherapy and their treatment will be adapted according to PET response after 3 cycles.
Other: Evaluation of first line treatment in patients with stage I and II LBCL
Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP.
Time Frame: 36 months
36 months
Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP.
Time Frame: 36 months
36 months
Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.
Time Frame: 36 months
36 months
Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time Frame: 36 months
36 months
Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time Frame: 36 months
36 months
Evaluate the prognostic value of Δ SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP
Time Frame: 36 months
36 months
Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6
Time Frame: 36 months
36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP)
Time Frame: 36 months
36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin
Time Frame: 36 months
36 months
Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Argentino de Tratamiento de la Leucemia Aguda

Investigators

  • Principal Investigator: Amalia Cerutti, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda
  • Study Chair: Astrid Pavlovsky, Dr., Grupo Argentino de Tratamiento de la Leucemia Aguda

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 Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GATLA 10-LNHDCG-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share study protocol

IPD Sharing Time Frame

The data will become available on June 2021, and will remain available until the end of the clinical trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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