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Trial Title:
Lowdose Nivolumab in Combination With AVD as Front Line Therapy for Classic Hodgkin's Lymphoma
NCT ID:
NCT05772624
Condition:
Safety Issues
Efficacy, Self
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Nivolumab
Conditions: Keywords:
Nivolumab
lowdose nivolumab
NAVD
hodgkin's lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
low dose nivolumab in combination with AVD
Description:
Nivolumab as an standard dose of 40mg in combination with AVD.
Arm group label:
LowN-AVD
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Dr Jose Eleuterio Gonzalez
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Perla R Colunga Pedraza, MD
Phone:
+52 8183486136
Email:
colunga.perla@gmail.com
Contact backup:
Last name:
Antonio Vega Mateos, MD
Phone:
+52 8183488510
Email:
antoniovegamat@gmail.com
Start date:
February 13, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Hospital Universitario Dr. Jose E. Gonzalez
Agency class:
Other
Source:
Hospital Universitario Dr. Jose E. Gonzalez
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772624
