Refractory / relapsed Hodgkin's lymphoma
Conditions
Sponsors
Medical Unicersity of Gdansk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Evaluation of disease advancement by PET examination at diagnosis. 3. Age =18 years old 4. ECOG 0-2 5. Presence of at least one measurable change 6. 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 7. 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). 8. Signing consent to participate in the clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 74 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Non-classical form of Hodgkin's lymphoma, 2. Performance status according to ECOG>2 3. Failure to perform PET scans during induction treatment in accordance with the inclusion criteria Fig. 4. Transformation of Hodgkin's lymphoma into another lymphoma 5. Central nervous system involvement, 6. Medical contraindications or patient's refusal to consolidate BGD rescue treatment with aHCT 7. Other cancer - active form or less than 5 years from cure, 8. Uncontrolled diabetes 9. Heart failure NYHA>2 or LVEF 5 x ULN) if unrelated to lymphoma, and Gilbert's syndrome 11. 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. 12. Pregnancy or breastfeeding, 13. Known hypersensitivity to any of the drugs used in the treatment. 14. The patient is unable to sign the informed consent form to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of the intervention based on early initiation of second-line treatment (Nivolumab) in patients with Hodgkin's lymphoma resistant to previously administered treatment, followed by BGD chemotherapy (2 cycles) and consolidation with autologous transplantation of hematopoietic stem cells (aHCT). Additionally, the predictive value of circulating free DNA of Hodgkin's lymphoma cells measured before autologous transplantation will be assessed. 1. Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N). 2. PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause. ;Primary end point(s): 1. Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N). 2. PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause. ;Timepoint(s) of evaluation of this end point: During follow-up after the end of treatment;Secondary Objective: Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment. Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause. Percentage of patients among whom aHCT was successfully performed. 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. The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3. Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment. 4. Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause. 5. Percentage of patients among whom aHCT was successfully performed. 6. 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. 7. The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5. ;Timepoint(s) of evaluation of this end point: 1. Positive and negative predictive value of circulating free DNA of Hodgkin's lymphoma cells measured before autologous transplantation compared to PET / CT scan performed at the same time. | — |
Countries
Poland
Contacts
Public ContactJan Maciej Zaucha
Medical University of Gdansk
Outcome results
None listed