Skip to main content
MedPathMedPath Home
Clinical Trials/2022-503090-11-00
2022-503090-11-00
Recruiting
Phase 2

Efficacy and safety of frontline tislelizumab in patients with de novo Hodgkin lymphoma unsuitable for standard frontline chemotherapy: a phase II, open-label study

Fondazione Italiana Linfomi Onlus10 sites in 1 country25 target enrollmentStarted: November 16, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Fondazione Italiana Linfomi Onlus
Enrollment
25
Locations
10
Primary Endpoint
The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study is aimed at evaluating efficacy in terms of overall response rate (ORR) of tislelizumab as frontline treatment in patients with untreated Hodgkin Lymphoma (HL) considered unsuitable for chemotherapy.

Eligibility Criteria

Ages
65 years to 65+ years (65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL)
  • •Subject voluntarily signs and dates an informed consent form approved by an National Ethics Committee prior to the initiation of any screening or study-specific procedures, indicating that they understand the purpose of and procedures required for the study and are willing to participate in it
  • •Subject must be able to adhere to the study visit schedule and other protocol requirements, and to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • •Patients >= 65 years ineligible for frontline standard chemotherapy (mainly due to medical comorbidities)
  • •Treatment naïve
  • •Measurable disease defined as presence of both fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion measurable in two diameters (and at least 1.5 cm in its major diameter)
  • •Indication for systemic treatment, i.e., all stages except IA without a large tumor burden, as radiotherapy is regarded curative in those patients
  • •Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
  • •Adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) > 10^9/L (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvment by lymphoma; Platelet > 50 x 10^9/L (without growth factor support or transfusion within 7 days of platelets measurement), unless due to bone marrow involvment by lymphoma; Hemoglobin > 8 g/dL (prior transfusion is acceptable); Creatinine clearance ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24-hour urine collection); Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 3.0 × upper limit of normal (ULN); Serum total bilirubin < 1.5 × ULN (or < 3 x ULN in case of documented Gilbert’s syndrome)
  • •Life expectancy ≥ 6 months

Exclusion Criteria

  • •Nodular lymphocyte predominant HL
  • •Any history of other active malignancies within 3 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent
  • •Any previous treatment (including radiation therapy) for HL
  • •History of severe hypersensitivity reactions to other monoclonal antibodies
  • •Concurrent participation in another therapeutic clinical trial
  • •Any active autoimmune disease requiring systemic treatment (including disease-modifying agents, corticosteroids, immunosuppressants) in the past 2 years. Note: Patients with the following diseases are not excluded and may proceed to further screening: type I diabetes under control; Hypothyroidism (provided it is managed with hormone replacement therapy only); Controlled celiac disease
  • •Has known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of dyspnea at rest or pulse oximetry of < 92% while breathing room air
  • •A history of previous exposure to anti-PD1, anti-PDL1 or anti-PDL2 or anti-CTLA-4 agents for any disease other than HL
  • •Use of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days from registration; Note: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • •Known infection with HIV, human T-cell lymphotropic virus-1, -2

Outcomes

Primary Outcomes

The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).

The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).

Secondary Outcomes

  • Duration of response (DoR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Disease free survival (DFS)
  • Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse event occurred from the IC signed to the end of the study (LPLV)

Investigators

Sponsor
Fondazione Italiana Linfomi Onlus
Sponsor Class
Patient organisation/association
Responsible Party
Principal Investigator
Principal Investigator

Prof. Pier Luigi Zinzani

Scientific

Fondazione Italiana Linfomi Onlus

Study Sites (10)

Loading locations...

Similar Trials

Completed
Phase 2
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.
2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
Recruiting
Phase 2
Use of LOncastuximab Tesirine in patients with RElapsed/Refractory Diffuse Large B-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) who have progressive disease after CAR T-cell treatment - LORELY
2024-516929-31-00Humanitas Mirasole S.p.A.50
Active, not recruiting
Phase 3
A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS 5)
2023-503916-33-00ADC Therapeutics S.A.277
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis
2023-505980-36-00F. Hoffmann-La Roche AG363
Completed
Phase 3
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (OptIMMize-1)
2023-504156-10-00Abbvie Deutschland GmbH & Co. KG72