Clinical trial NCT05757466: Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma
Official title: Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin lymphoma
Prolgolimab
PD-1 inhibitors
Bendamustine
Immunotherapy
Relapsed/refractory
Autologous stem cell transplantation,
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
Collaborators: name: N.N. Petrov National Medical Research Center of Oncology
First posted: 2023-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).

The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
* Age 18-70 y
* Ejection fraction not less than 50%
* No severe concurrent illness
* 0-2 ECOG status
* 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.

Exclusion Criteria:

* 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
* Use of PD-1 inhibitors or bendamustine in the 1st line of therapy

Primary outcomes:
measure: Overall response rate during prolgolimab monotherapy
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
timeFrame: 12 months
measure: Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
timeFrame: 24 months
measure: Overall response rate during combination therapy (prolgolimab+bendamustine)
timeFrame: 24 months
measure: 1-year and 2-year overall survival
timeFrame: 24 months
measure: 1-year and 2-year progression-free survival
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Pavlov Medical University
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov National Medical Research Center of Oncology
Study officials:
affiliation: St. Petersburg State Pavlov Medical University
name: Kirill Lepik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Petersburg State Pavlov Medical University
name: Natalia Mikhailova, MD
role: STUDY_CHAIR
References: