Use of nivolumab (N) followed by chemotherapy: bendamustine, gemcitabine and dexamethasone (BGD) with autologous bone marrow transplantation in patients with Hodgkin’s lymphoma refractory to 1-line therapy.
Key facts
- Where
- Cracow, Gdansk, Gliwice, Katowice, Lodz, Olsztyn, Warsaw és Wroclaw, LengyelországSee the 9 sites
- Phase
- 2. fázis
Where in Lengyelország
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországTaking people
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországTaking people
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, LengyelországTaking people
- Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego SUM W KatowicachKatowice, LengyelországTaking people
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, LengyelországTaking people
- Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w OlsztynieOlsztyn, LengyelországTaking people
- Instytut Hematologii I TransfuzjologiiWarsaw, LengyelországTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Gdansk
- Trial code
- EU 2024-515064-31-00
- Record updated
- 2024. november 5.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; Evaluation of disease advancement by PET examination at diagnosis; Age ≥18 years old; ECOG 0-2; Presence of at least one measurable change; 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; 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); Signing consent to participate in the clinical trial.
Exclusion: Medical contraindications or patient's refusal to consolidate BGD rescue treatment with aHCT; 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; Known hypersensitivity to any of the drugs used in the treatment; Failure to perform PET scans during induction treatment in accordance with the inclusion criteria; Other cancer - active form or less than 5 years from cure; Uncontrolled diabetes; Liver failure (bilirubin 1.5 x ULN, SGOT > 5 x ULN) if unrelated to lymphoma, and Gilbert's syndrome; Heart failure NYHA>2 or LVEF<45%; Non-classical form of Hodgkin's lymphoma; Pregnancy or breastfeeding; The patient is unable to sign the informed consent form to participate in the study; Performance status according to ECOG>2; Transformation of Hodgkin's lymphoma into another lymphoma; Central nervous system involvement.