Actively Recruiting
Radiation Free Chemotherapy for Early Hodgkin Lymphoma
Led by Medical University of Gdansk · Updated on 2021-08-12
160
Participants Needed
27
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The results of the present study will provide information on short-term safety and efficacy of a iPET and MTV-adapted therapeutic strategy, aimed to assess the feasibility and safety on immediate disease control of a standard ABVD chemotherapy without any further treatment in patients with a very low risk or treatment failure. A second very important endpoint will be the efficacy of INRT "on demand" followed by Nivolumab maintenance for one year to rescue patients failing first-line treatment and relapsing with the pattern of "limited relapse" in terms of 3-Y failure from 2 relapse (FF2R). Patients entering into the study will be also asked to participate to a long-term follow up study (beyond ten years) to assess the prevalence of late-onset cardiovascular effects and secondary tumors in the cohort of patients enrolled in the experimental and control arm of the study. An exploratory endpoint has been also added such as the role of Minimal Residual Disease (MRD) detection by cell-free DNA assay on peripheral blood samples obtained during treatment in predicting long-term disease control.
CONDITIONS
Official Title
Radiation Free Chemotherapy for Early Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-60
- Treatment-nafve Hodgkin Lymphoma patients with Ann Arbor stage I or II A non-bulky disease
- Histologically confirmed classical Hodgkin Lymphoma according to WHO classification
- ECOG performance status between 0 and 2
- Hemoglobin greater than 8 gr./dL
- Absolute neutrophil count at least 1,000/bcL
- Platelet count at least 100,000/bcL
- Voluntary written consent to participate
- Serum creatinine less than 2.0 mg/dL or creatinine clearance above 40 mL/min
- Total bilirubin less than 2.0 times the upper limit of normal unless Gilbert syndrome
- ALT and AST less than 3 times the upper limit of normal
- Female patients must be postmenopausal for at least 1 year or agree to use two effective contraception methods or true abstinence if fertile
- Male patients must agree to use barrier contraception or abstinence
You will not qualify if you...
- Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
- Bulky disease defined as nodal mass 10 cm or larger
- Presence of B symptoms
- Disease involving extra nodal sites
- Female patients who are both lactating and breastfeeding or test positive for pregnancy at screening or before first dose
- Uncompensated diabetes requiring insulin
- Serious medical or psychiatric illness interfering with treatment
- Known HIV infection
- Active hepatitis B or C infection
- Severely impaired lung or renal function
- Diagnosis or treatment for another malignancy within 3 years, except completely resected non-melanoma skin cancer or carcinoma in situ
- Active autoimmune disorder treated with immunosuppressive drugs
- Left ventricular ejection fraction below 50%
- Myocardial infarction within 2 years prior to study entry
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Hematology Department IRCCS Policlinico San Matteo
Pavia, P.le Golgi 19, Italy, 27100
Actively Recruiting
2
Ospedale Papa Giovanni XXIII
Bergamo, Piazza OMS, 1, Italy, 24127
Not Yet Recruiting
3
Istituto Europeo di Oncologia
Milan, Via Giuseppe Ripamonti 435, Italy, 20141
Not Yet Recruiting
4
Hematology Department Azienda Ospedaliera S. Croce e Carle
Cuneo, Via Michele Coppino, 26, Italy, 12100
Not Yet Recruiting
5
Azienda Ospedaliera Universitaria Policlinico Federico II
Naples, Via S.Pansini, 5, Italy, 80131
Actively Recruiting
6
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Viale Orazio Flacco, 65, Italy, 70124
Not Yet Recruiting
7
Policlinico Università Tor Vergata
Roma, Viale Oxford, 81, Italy, 00133
Not Yet Recruiting
8
Azienda Ospedaliero - Universitaria Ospedali Riuniti
Ancona, Italy
Not Yet Recruiting
9
Azienda Ospedaliera G. Brotzu - Ospedale Businco
Cagliari, Italy
Not Yet Recruiting
10
Divisione Universitaria di Onco-Ematologia
Monza, Italy
Not Yet Recruiting
11
Azienda Ospedaliera di Padova Dipartimento di Medicina Interna
Padova, Italy
Not Yet Recruiting
12
Ospedali Riuniti Villa Sofia
Palermo, Italy
Not Yet Recruiting
13
Gdański Uniwersytet Medyczny Department of Hematology and Transplantology
Gdansk, Poland
Actively Recruiting
14
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Not Yet Recruiting
15
Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa
Warsaw, Poland
Not Yet Recruiting
16
Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu
Wroclaw, Poland
Not Yet Recruiting
17
Hospital Universitario Central de Asturias
Oviedo, Av. Roma, Spain, 33011
Not Yet Recruiting
18
Hospital Universitario 12 de Octubre
Madrid, Avda de Córdoba, Spain, 28041
Not Yet Recruiting
19
Hospital Duran i Reynals. Institut Catala d'Oncologia
Barcelona, Avinguda de La Granvia de l'Hospitalet, 199-203, Spain, 08908
Not Yet Recruiting
20
Hospital Germans Trias i Pujol-ICO Badalona
Carretera de Canyet, Barcelona, Spain, 08916
Not Yet Recruiting
21
Hospital Universitario Vall d'Hebron
Passeig de La Vall d'Hebron, 119-129, Barcelona, Spain, 08035
Not Yet Recruiting
22
Hospital Clinic de Barcelona
Barcelona, C. de Villarroel, 170, Spain, 08036
Not Yet Recruiting
23
Hospital General Universitario Gregorio Marañon
Madrid, Calle Del Dr. Esquerdo, Spain, 28007
Not Yet Recruiting
24
Hospital Universitario Marques de Valdecilla
Av. de Valdecilla, 25, Cantabria, Spain, 39008
Not Yet Recruiting
25
Hospital Universitario Ramón y Cajal
Madrid, Ctra. de Colmenar Viejo Km. 9,100, Spain, 28034
Not Yet Recruiting
26
Hospital Universitario de Salamanca
Salamanca, P.º de San Vicente, 58, Spain, 37007
Not Yet Recruiting
27
Hospital Universitario Virgen del Rocio
Av. Manuel Siurot, Sevilla, Spain, 41013
Not Yet Recruiting
Research Team
J
Jan M Zaucha, Professor, PhD, MD
CONTACT
M
Marta Bednarek, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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