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New treatment option for Hodgkin Lymphoma
Official title Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
ClinicalTrials.gov ID: NCT07234487
What this study is testing
What is Nivo-AVD?
Nivo-AVD is an investigational medicine, 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
- Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 60
You may be able to join if
- Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific...
- Patients with evidence of lesion extent assessed by whole-body PET/CT;
- Patients aged 18-60 years;
- ECOG 0-2;
- Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after...
You likely can't join if
- Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
- Respiratory failure \> grade 1 at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Active or prior documented autoimmune disease requiring systemic treatment
- Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
See the full eligibility criteria
- Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;
- Patients with evidence of lesion extent assessed by whole-body PET/CT;
- Patients aged 18-60 years;
- ECOG 0-2;
- Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;
- Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
- Respiratory failure \> grade 1 at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Active or prior documented autoimmune disease requiring systemic treatment
- Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
- Hypersensitivity or allergy to study drugs
- Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
- Simultaneous use of drugs or medical devices studied in other clinical trials
The study team makes the final eligibility decision.
Where it's taking place
- 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.