Radiation Free Chemotherapy for Early Hodgkin Lymphoma
RAFTING
Radiation-Free Therapy for the Initial Treatment of Good Prognosis Early Non-bulky HL, Defined by a Low Metabolic Tumor Volume and a Negative Interim PET After 2 Chemotherapy Cycles- RAFTING
1 other identifier
interventional
160
3 countries
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2021
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2021
CompletedFirst Submitted
Initial submission to the registry
April 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2026
ExpectedAugust 12, 2021
August 1, 2021
1.6 years
April 22, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy exploration in terms of 3-Y PFS of chemotherapy alone
To explore the efficacy, in terms of 3-Y PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by both a low MTV and a negative interim PET after 2 courses of ABVD
During follow-up (36 months) after the end of treatment
Secondary Outcomes (4)
Efficacy exploration in terms of 3-Y PFS of chemotherapy plus Nivolumab
During follow-up (36 months) after the end of treatment
Efficacy exploration in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance
During follow-up (36 months) after the end of treatment
Safety exploration in terms of 3-Y OS of a treatment with chemotherapy alone
During follow-up (36 months) after the end of treatment
Evaluation the ability of cell-free DNA (cfDNA) assay
During follow-up (36 months) after the end of treatment
Study Arms (1)
Study group
EXPERIMENTALNivolumab, total dose 5760 mg milligram
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged 18-60.
- Treatment-naïve, HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A);
- Patients must have histologically confirmed classical HL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocytes rich, lymphocytes depleted, or classical HL NOS \[not otherwise specified\];
- ECOG performance status 0-2
- Hemoglobin must be \> 8 gr./dL
- Absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 100,000/μL
- Voluntary written consent to take part to the study
- Serum Creatinine \< 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance \> 40 mL/minute
- Total bilirubin must be \< 2.0 x the upper limit of normal (ULN) unless known Gilbert syndrome
- ALT or AST must be \< 3 x the upper limit of normal.
- Female patients: if postmenopausal for at least 1 year before enrolment or, if fertile - agreeing to practice 2 effective methods of contraception or agreeing to practice true abstinence.
- Male patients should agree to practice barrier contraception or to practice abstinence
You may not qualify if:
- Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma;
- Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters);
- B symptoms;
- Extra nodal site involved by disease;
- Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug;
- Uncompensated diabetes mellitus requiring insulin therapy;
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol;
- Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA;
- Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA;
- Severely impaired, lung and renal function;
- Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection;
- Active autoimmune disorder in treatment with immunosuppressive drugs
- A left-ventricular ejection fraction \< 50%;
- Myocardial infarction within 2 years of study entry.
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Hematology Department IRCCS Policlinico San Matteo
Pavia, P.le Golgi 19, 27100, Italy
Ospedale Papa Giovanni XXIII
Bergamo, Piazza OMS, 1, 24127, Italy
Istituto Europeo di Oncologia
Milan, Via Giuseppe Ripamonti 435, 20141, Italy
Hematology Department Azienda Ospedaliera S. Croce e Carle
Cuneo, Via Michele Coppino, 26, 12100, Italy
Azienda Ospedaliera Universitaria Policlinico Federico II
Napoli, Via S.Pansini, 5, 80131, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Viale Orazio Flacco, 65, 70124, Italy
Policlinico Università Tor Vergata
Roma, Viale Oxford, 81, 00133, Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti
Ancona, Italy
Azienda Ospedaliera G. Brotzu - Ospedale Businco
Cagliari, Italy
Divisione Universitaria di Onco-Ematologia
Monza, Italy
Azienda Ospedaliera di Padova Dipartimento di Medicina Interna
Padua, Italy
Ospedali Riuniti Villa Sofia
Palermo, Italy
Gdański Uniwersytet Medyczny Department of Hematology and Transplantology
Gdansk, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu
Wroclaw, Poland
Hospital Universitario Central de Asturias
Oviedo, Av. Roma, 33011, Spain
Hospital Universitario 12 de Octubre
Madrid, Avda de Córdoba, 28041, Spain
Hospital Duran i Reynals. Institut Catala d'Oncologia
Barcelona, Avinguda de La Granvia de l'Hospitalet, 199-203, 08908, Spain
Hospital Germans Trias i Pujol-ICO Badalona
Carretera de Canyet, Barcelona, 08916, Spain
Hospital Universitario Vall d'Hebron
Passeig de La Vall d'Hebron, 119-129, Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, C. de Villarroel, 170, 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Calle Del Dr. Esquerdo, 28007, Spain
Hospital Universitario Marques de Valdecilla
Av. de Valdecilla, 25, Cantabria, 39008, Spain
Hospital Universitario Ramón y Cajal
Madrid, Ctra. de Colmenar Viejo Km. 9,100, 28034, Spain
Hospital Universitario de Salamanca
Salamanca, P.º de San Vicente, 58, 37007, Spain
Hospital Universitario Virgen del Rocio
Av. Manuel Siurot, Sevilla, 41013, Spain
Related Publications (1)
Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
PMID: 40135712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan M Zaucha, Professor, PhD, MD
Medical University of Gdansk
- PRINCIPAL INVESTIGATOR
Andrea Gallamini, Professor, PhD, MD
Research and Clinical Innovation Department of the Lacassagne Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2021
First Posted
April 30, 2021
Study Start
March 4, 2021
Primary Completion
September 30, 2022
Study Completion (Estimated)
July 2, 2026
Last Updated
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share