Treatment adaptation for patients with early-stage DLBCL using PET-CT
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)
This study is testing if changing the treatment for patients with early-stage DLBCL based on PET-CT scan results can help them live longer and stay cancer-free.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, doxorubicin, prednisone |
| Locations | 7 sites (Paraná, Entre Ríos and 6 other locations) |
| Trial ID | NCT05078840 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the feasibility and efficacy of adapting treatment based on PET-CT results in patients with limited stage DLBCL who do not have poor prognostic factors. Patients aged over 17 will receive three cycles of R-CHOP chemotherapy, followed by a PET-CT scan to assess treatment response. Depending on the PET-CT results, treatment will be adjusted, with options including additional chemotherapy or radiation therapy. The study aims to monitor overall survival and progression-free survival over a three-year period.
Who should consider this trial
Good fit: Ideal candidates are adults over 17 years old with a confirmed diagnosis of stage I or II DLBCL and no significant risk factors.
Not a fit: Patients with advanced stages of DLBCL or those with poor prognostic factors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with early-stage DLBCL.
How similar studies have performed: While similar approaches using PET-CT for treatment adaptation have shown promise, this specific study's methodology is novel in its focus on early-stage DLBCL without risk factors.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paraná, Entre Ríos and 6 other locations
- Instituto Privado de Hematologia y Hemoterapia — Paraná, Entre Ríos, Argentina (Recruiting)
- Hospital Italiano de La Plata — La Plata, Provincia De Buenos Aires, Argentina (Recruiting)
- IDHEA Clínica Hematológica — Rosario, Santa Fe, Argentina (Recruiting)
- Fundaleu — Caba, Argentina (Recruiting)
- Hospital Italiano de Buenos Aires — Caba, Argentina (Recruiting)
- Clínica Universitaria Reina Fabiola — Córdoba, Argentina (Recruiting)
- Hospital Privado de Córdoba — Córdoba, Argentina (Recruiting)
Study contacts
- Principal investigator: Amalia Cerutti, Dr. — Grupo Argentino de Tratamiento de la Leucemia Aguda
- Study coordinator: Astrid Pavlovsky, Dr.
- Email: astridp@intramed.net
- Phone: 5491150613683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.