Efficacy, Self, Safety Issues
Conditions
Keywords
Nivolumab, lowdose nivolumab, NAVD, hodgkin's lymphoma
Brief summary
This study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with AVD (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic Hodgkin's lymphoma.
Detailed description
The main objective of this project is to prove the efficacy and safety of Nivolumab used as an standard dose of 40mg ( as the lowest available presentation) in combination with AVD as frontline therapy for Hodgkin's lymphoma. Patients classification. We will categorize patients in three groups as follows: 1. Early stages by Ann-arbor classification (I,II) with no risk factors (as stablished by NCCN's guidelines criteria). 2. Early stages by Ann.arbor classification (I,II) with risk factors ( as stablished by NCCN's guidelines criteria). 3. Advanced stages by Ann-arbor classification (III,IV). Methodology: * Patients will receive two initial cycles of NAVD therapy ( each with two applications in day 1 and 15) and then will be evaluated with an interim PET/CT after completing cycle 2. * According to the PET C/T results, patients will be categorized as fast responsers (patients who achieve Deauville 1-3 classification) and low responsers ( patients who achieve Deauville 4-5). * Fast responsers will receive following cycles without nivolumab (2 extra cycles for patients categorized as early stage with no risk factors, 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages). * Patients will receive medical evaluation at first meeting, during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria. * Adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications.
Interventions
DRUGlow dose nivolumab in combination with AVD
Nivolumab as an standard dose of 40mg in combination with AVD.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with recent diagnosis of classic Hodgkin's lymphoma demonstrated by incisional or excisional biopsy of adenopathy. * Treatment naive patients. * Any stage * Any functional status.
Exclusion criteria
* Patients with refractory or relapsed disease. * Patients with non classical variety. * Patients with chronic or active infections at the moment of recruiting. * Patients younger than 16 years old. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine general response | Six weeks after completion of therapy. | To determine patients achieving either a complete response or a partial response as demonstrated with PET C/T evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response duration | up to 2 years | To evaluate the duration of the response achieved with the therapy. |
| Adverse effects | through the study completion and up to 6 months | To record the side effects associated with the treatment as stablished by the international guidelines for chemotherapy and immunotherapy. |
Countries
Mexico
Contacts
Primary ContactDavid Gomez Almaguer, MD
Outcome results
None listed