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New treatment option for Hodgkin Lymphoma
Official title PD-1 Inhibitors Maintenance for cHL Post-autoHCT
ClinicalTrials.gov ID: NCT06812858
What this study is testing
What is Nivolumab, Pembrolizumab?
Nivolumab, Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 18-70 years;
- Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;
- High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the...
- Complete or partial response by PET/CT after auto-HSCT
- No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
You likely can't join if
- Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of...
- Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;
- Respiratory failure of more than 1 degree at the time of inclusion in the study;
- Unstable haemodynamics at the time of inclusion in the study;
- Acute bacterial, viral or fungal infection at the time of inclusion;
- Active autoimmune diseases (people with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases...
See the full eligibility criteria
- 18-70 years;
- Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;
- High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable...
- Complete or partial response by PET/CT after auto-HSCT
- No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
- Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L);
- ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI
- Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;
- Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;
- Respiratory failure of more than 1 degree at the time of inclusion in the study;
- Unstable haemodynamics at the time of inclusion in the study;
- Acute bacterial, viral or fungal infection at the time of inclusion;
- Active autoimmune diseases (people with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic...
- Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;
- Somatic or psychiatric pathology that prevents the signing of informed consent;
The study team makes the final eligibility decision.
Where it's taking place
- Astana, Kazakhstan
- Moscow, Russia
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Astana, Kazakhstan; Moscow, Russia; Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.