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Hodgkin LymphomaPhase 2RAFTINGNCT04866654

Radiation Free Chemotherapy for Early Hodgkin Lymphoma

A Phase 2 study testing Nivolumab 10 MG/ML in people with Hodgkin Lymphoma, run by Medical University of Gdansk at 27 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Nivolumab 10 MG/ML
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
27 sitesin 3 countries
Study dates
4 Mar 2021to 2 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

27 sites in 3 countries.

Jan M Zaucha, Professor, PhD, MD contact

58 584 43 40 ext. 0048

jzaucha@gumed.edu.pl

Marta Bednarek, PhD contact

58 349 18 85 ext. 0048

marta.bednarek@gumed.edu.pl

27 sites in 3 countries

Italy12 sites, 12 recruiting

  • Azienda Ospedaliero - Universitaria Ospedali Riuniti

    Ancona

    Guido Gini, MD, PhD

    Not yet recruiting

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, Viale Orazio Flacco, 65, 70124

    Attilio Guarini, MD, PhD

    Not yet recruiting

  • Ospedale Papa Giovanni XXIII

    Bergamo, Piazza OMS, 1, 24127

    Alessandro Rambaldi, MD, PhD

    Not yet recruiting

  • Azienda Ospedaliera G. Brotzu - Ospedale Businco

    Cagliari

    Giorgio La Nasa, MD, PhD

    Not yet recruiting

  • Hematology Department Azienda Ospedaliera S. Croce e Carle

    Cuneo, Via Michele Coppino, 26, 12100

    Roberto Sorasio, MD, PhD

    Not yet recruiting

  • Istituto Europeo di Oncologia

    Milan, Via Giuseppe Ripamonti 435, 20141

    Corrado Tarella, MD, PhD

    Not yet recruiting

  • Divisione Universitaria di Onco-Ematologia

    Monza

    Silvia Bolis, MD, PhD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Policlinico Federico II

    Naples, Via S.Pansini, 5, 80131

    Marco Picardi, MD, PhD

    Recruiting

  • Azienda Ospedaliera di Padova Dipartimento di Medicina Interna

    Padova

    Livio Trentin, MD, PhD

    Not yet recruiting

  • Ospedali Riuniti Villa Sofia

    Palermo

    Caterina Patti, MD, PhD

    Not yet recruiting

  • Hematology Department IRCCS Policlinico San Matteo

    Pavia, P.le Golgi 19, 27100

    Manuel Gotti, MD, PhD, 347 9797989 ext. +39, Ma.Gotti@smatteo.pv.it

    Recruiting

  • Policlinico Università Tor Vergata

    Roma, Viale Oxford, 81, 00133

    Maria Cantonetti, MD, PhD

    Not yet recruiting

Other trials in Italy

Spain11 sites, 11 recruiting

  • Hospital Universitario Marques de Valdecilla

    Av. de Valdecilla, 25, Cantabria, 39008

    Javier Nuñez Cespedes, MD, PhD

    Not yet recruiting

  • Hospital Universitario Virgen del Rocio

    Av. Manuel Siurot, Sevilla, 41013

    Jorge Rodríguez Garcia, MD, PhD

    Not yet recruiting

  • Hospital Duran i Reynals. Institut Catala d'Oncologia

    Barcelona, Avinguda de La Granvia de l'Hospitalet, 199-203, 08908

    Eva Domingo Domenech, MD, PhD

    Not yet recruiting

  • Hospital Clinic de Barcelona

    Barcelona, C. de Villarroel, 170, 08036

    Carmen Martinez Munoz, MD, PhD

    Not yet recruiting

  • Hospital Germans Trias i Pujol-ICO Badalona

    Carretera de Canyet, Barcelona, 08916

    Miriam Moreno Velazquez, MD, PhD

    Not yet recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Avda de Córdoba, 28041

    Antonia Rodriguez-Izquierdo

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, Calle Del Dr. Esquerdo, 28007

    Mariana Bastos-Oreiro, MD, PhD

    Not yet recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Ctra. de Colmenar Viejo Km. 9,100, 28034

    Francisco Javier Lopez Jimenez, MD, PhD

    Not yet recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Av. Roma, 33011

    Ana Pilar Gonzales Rodriguez, MD, PhD

    Not yet recruiting

  • Hospital Universitario Vall d'Hebron

    Passeig de La Vall d'Hebron, 119-129, Barcelona, 08035

    Cecilia Carpio, MD, PhD

    Not yet recruiting

  • Hospital Universitario de Salamanca

    Salamanca, P.º de San Vicente, 58, 37007

    Roman Garcia Sanz, MD, PhD

    Not yet recruiting

Other trials in Spain

Poland4 sites, 4 recruiting

  • Gdański Uniwersytet Medyczny Department of Hematology and Transplantology

    Gdansk

    Jan M Zaucha, Professor, PhD, MD, 58 584 43 40 ext. 0048, jzaucha@gumed.edu.pl

    Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow

    Agnieszka Giza, PhD, MD

    Not yet recruiting

  • Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa

    Warsaw

    Ewa Paszkiewicz-Kozik, PhD, MD

    Not yet recruiting

  • Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu

    Wroclaw

    Tomasz Wrobel, Professor, PhD, MD, 71 7841764

    Not yet recruiting

Other trials in Poland

About this study

Official title: 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

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.

Being tested
Nivolumab 10 MG/ML
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab 10 MG/MLDrug

    Nivolumab, 100 mg, 10 mg/ml

Study groups in NCT04866654
Study groupRoleWhat they receive
Study groupExperimentalNivolumab, total dose 5760 mg milligram
Receives: Drug: Nivolumab 10 MG/ML

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During follow-up (36 months) after the end of treatment

Secondary outcomes (4)

  1. Efficacy exploration in terms of 3-Y PFS of chemotherapy plus Nivolumab

    To explore the efficacy in terms of 3-Y PFS of CMT plus Nivolumab in high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both

    Measured: During follow-up (36 months) after the end of treatment

  2. 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

    To explore the efficacy in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance in patients relapsing with the pattern of "limited relapse" (see below) for the entire group (relapsed and non-relapsed) of low-risk patients (with low MTV and negative PET- 2) high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both

    Measured: During follow-up (36 months) after the end of treatment

  3. Safety exploration in terms of 3-Y OS of a treatment with chemotherapy alone

    To explore the safety in terms of 3-Y OS of a treatment with chemotherapy alone in low-risk early-stage (I-IIA) HL patients, defined by a low Metabolic Tumor Volume negative interim PET after 2 ABVD courses

    Measured: During follow-up (36 months) after the end of treatment

  4. Evaluation the ability of cell-free DNA (cfDNA) assay

    To evaluate the ability of cell-free DNA (cfDNA) assay to detect an impending relapse during follow-up in low-risk patients treated with chemotherapy alone�k�

    Measured: During follow-up (36 months) after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start4 Mar 2021
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion2 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866654
Sponsor's protocol ID
NBK132/1/2020
Acronym
RAFTING
Status last verified
Aug 2021
First submitted
22 Apr 2021
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40135712

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab 10 MG/ML in people with Hodgkin Lymphoma, run by Medical University of Gdansk at 27 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan M Zaucha, Professor, PhD, MD (58 584 43 40 ext. 0048, jzaucha@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy exploration in terms of 3-Y PFS of chemotherapy alone (time frame: During follow-up (36 months) after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04866654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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