NIVOLUMAB for Classical Hodgkin lymphoma (refractory or relapsed)

Inclusion criteria

• {"criterion_text":"-Patients with recurrence of previously confirmed histopathologically confirmed classical Hodgkin's lymphoma based on the local pathology report according to the WHO 2016 classification, after the first line of treatment initially diagnosed in stage IIA but with a large metabolic tumor volume or the presence of a massive lesion (>10cm) or diagnosed in stage IIB- IV OR Patients with primary refractory classical Hodgkin's lymphoma in stage IIA with a large metabolic tumor volume (>147 ml) or the presence of a massive lesion (>10 cm) or in stage IIB-IV. Primary resistance to treatment will be defined by a positive iPET2 test (Deauville scale scores 4 and 5) performed after the 2nd cycle of first-line chemotherapy; and in patients with a negative iPET2 test result (Deauville scale scores 1, 2, 3) the occurrence of active disease confirmed by PET-CT within three months of the end of first-line chemotherapy."}
• {"criterion_text":"-Evaluation of disease advancement by PET examination at diagnosis."}
• {"criterion_text":"-Age ≥18 years old"}
• {"criterion_text":"-ECOG 0-2"}
• {"criterion_text":"-Presence of at least one measurable change"}
• {"criterion_text":"-Consent to effective contraception during the study using contraception for 14 months for women and 11 months for men after the last dose of immuno-chemotherapy"}
• {"criterion_text":"-In women of childbearing age, a negative serum pregnancy test result at screening and consent to use highly effective methods of contraception during the study and for 14 months after the last dose of chemotherapy (except for patients over 50 years of age with natural amenorrhea for a period of at least 12 months or after bilateral salpingoophorectomy or hysterectomy)."}
• {"criterion_text":"-Signing consent to participate in the clinical trial"}

Exclusion criteria

• {"criterion_text":"-Non-classical form of Hodgkin's lymphoma"}
• {"criterion_text":"-Liver failure (bilirubin 1.5 x ULN, SGOT > 5 x ULN) if unrelated to lymphoma, and Gilbert's syndrome"}
• {"criterion_text":"-HIV infection, active HBV, HCV, CMV infection. In the case of hepatitis B infection and the presence of abHBc, it is necessary to evaluate the PCR DNA of the virus and start prophylactic treatment in accordance with the advice of an infectious disease doctor."}
• {"criterion_text":"-Pregnancy or breastfeeding"}
• {"criterion_text":"-Known hypersensitivity to any of the drugs used in the treatment."}
• {"criterion_text":"-The patient is unable to sign the informed consent form to participate in the study."}
• {"criterion_text":"-Performance status according to ECOG>2"}
• {"criterion_text":"-Failure to perform PET scans during induction treatment in accordance with the inclusion criteria"}
• {"criterion_text":"-Transformation of Hodgkin's lymphoma into another lymphoma"}
• {"criterion_text":"-Central nervous system involvement"}
• {"criterion_text":"-Medical contraindications or patient's refusal to consolidate BGD rescue treatment with aHCT"}
• {"criterion_text":"-Other cancer - active form or less than 5 years from cure"}
• {"criterion_text":"-Uncontrolled diabetes"}
• {"criterion_text":"-Heart failure NYHA>2 or LVEF<45%"}

Primary endpoints

• {"endpoint_text":"-Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).","definition_or_measurement_approach":"CMR rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab as stated in the endpoint."}
• {"endpoint_text":"-PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.","definition_or_measurement_approach":"Time from initiation of Nivolumab treatment to progression (PD) or death from any cause."}

Secondary endpoints

• {"endpoint_text":"-Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment.","definition_or_measurement_approach":"Percentage of patients achieving complete or partial metabolic responses after N, BGD, and aHCT (OMRR defined as CMR + PMR per protocol text)."}
• {"endpoint_text":"-Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause.","definition_or_measurement_approach":"Time from initiation of Nivolumab treatment to death from any cause."}
• {"endpoint_text":"-Percentage of patients among whom aHCT was successfully performed.","definition_or_measurement_approach":"Proportion of enrolled patients who underwent successful autologous hematopoietic stem cell transplantation (aHCT)."}
• {"endpoint_text":"-Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.","definition_or_measurement_approach":"Frequency of adverse events graded >2 according to CTCAE v5.0."}
• {"endpoint_text":"-The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.","definition_or_measurement_approach":"Count of grade 3 and 4 adverse reactions as assessed by CTCAE v5.0."}

Poland

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

05-11-2024

Processing Time Days

43

Number Of Sites

9

Number Of Participants

84

Primary sponsor

Full Name

Medical University Of Gdansk

Organisation Type

Educational Institution

Country Of Registered Address

Poland