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Radiation-free chemotherapy for early Hodgkin lymphoma

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

PHASE2 · Medical University of Gdansk · NCT04866654

This study is testing a new chemotherapy treatment without radiation for people with early Hodgkin lymphoma to see if it can effectively control the disease and if a follow-up drug can help prevent relapses.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorMedical University of Gdansk (other)
Drugs / interventionsNivolumab, chemotherapy
Locations27 sites (Pavia, P.le Golgi 19 and 26 other locations)
Trial IDNCT04866654 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a chemotherapy regimen using ABVD without radiation for patients with early-stage Hodgkin lymphoma who are at very low risk of treatment failure. It aims to assess immediate disease control and the effectiveness of Nivolumab as a maintenance therapy for patients experiencing limited relapse. Participants will also be involved in a long-term follow-up to monitor late-onset cardiovascular effects and secondary tumors. The study includes an exploratory endpoint focusing on the detection of Minimal Residual Disease.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve patients aged 18-60 with early-stage, non-bulky Hodgkin lymphoma.

Not a fit: Patients with advanced-stage Hodgkin lymphoma or those who have previously received treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer treatment option for patients with early Hodgkin lymphoma by reducing the need for radiation therapy.

How similar studies have performed: While there have been studies exploring chemotherapy without radiation, this specific approach with Nivolumab is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Pavia, P.le Golgi 19 and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hodgkin Lymphoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.