Radiation Free Chemotherapy for Early Hodgkin Lymphoma (RAFTING)

August 11, 2021 updated by: Medical University of Gdansk

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jan M Zaucha, Professor, PhD, MD
  • Phone Number: 0048 58 584 43 40
  • Email: jzaucha@gumed.edu.pl

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria Ospedali Riuniti
        • Contact:
          • Guido Gini, MD, PhD
      • Cagliari, Italy
        • Not yet recruiting
        • Azienda Ospedaliera G. Brotzu - Ospedale Businco
        • Contact:
          • Giorgio La Nasa, MD, PhD
      • Monza, Italy
        • Not yet recruiting
        • Divisione Universitaria di Onco-Ematologia
        • Contact:
          • Silvia Bolis, MD, PhD
      • Padova, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Padova Dipartimento di Medicina Interna
        • Contact:
          • Livio Trentin, MD, PhD
      • Palermo, Italy
        • Not yet recruiting
        • Ospedali Riuniti Villa Sofia
        • Contact:
          • Caterina Patti, MD, PhD
    • P.le Golgi 19
      • Pavia, P.le Golgi 19, Italy, 27100
        • Recruiting
        • Hematology Department IRCCS Policlinico San Matteo
        • Contact:
    • Piazza OMS, 1
      • Bergamo, Piazza OMS, 1, Italy, 24127
        • Not yet recruiting
        • Ospedale Papa Giovanni Xxiii
        • Contact:
          • Alessandro Rambaldi, MD, PhD
    • Via Giuseppe Ripamonti 435
      • Milano, Via Giuseppe Ripamonti 435, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo di Oncologia
        • Contact:
          • Corrado Tarella, MD, PhD
    • Via Michele Coppino, 26
      • Cuneo, Via Michele Coppino, 26, Italy, 12100
        • Not yet recruiting
        • Hematology Department Azienda Ospedaliera S. Croce e Carle
        • Contact:
          • Roberto Sorasio, MD, PhD
    • Via S.Pansini, 5
      • Napoli, Via S.Pansini, 5, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Federico II
        • Contact:
          • Marco Picardi, MD, PhD
    • Viale Orazio Flacco, 65
      • Bari, Viale Orazio Flacco, 65, Italy, 70124
        • Not yet recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II
        • Contact:
          • Attilio Guarini, MD, PhD
    • Viale Oxford, 81
      • Roma, Viale Oxford, 81, Italy, 00133
        • Not yet recruiting
        • Policlinico Università Tor Vergata
        • Contact:
          • Maria Cantonetti, MD, PhD
  • Poland
      • Gdańsk, Poland
        • Recruiting
        • Gdański Uniwersytet Medyczny Department of Hematology and Transplantology
        • Contact:
      • Kraków, Poland
        • Not yet recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
        • Contact:
          • Agnieszka Giza, PhD, MD
      • Warszawa, Poland
        • Not yet recruiting
        • Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa
        • Contact:
          • Ewa Paszkiewicz-Kozik, PhD, MD
      • Wrocław, Poland
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu
        • Contact:
          • Tomasz Wrobel, Professor, PhD, MD
          • Phone Number: 71 7841764
  • Spain
    • Av. Roma
      • Oviedo, Av. Roma, Spain, 33011
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Ana Pilar Gonzales Rodriguez, MD, PhD
    • Avda De Córdoba
      • Madrid, Avda De Córdoba, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 De Octubre
        • Contact:
          • Antonia Rodriguez-Izquierdo
    • Avinguda De La Granvia De l'Hospitalet, 199-203
      • Barcelona, Avinguda De La Granvia De l'Hospitalet, 199-203, Spain, 08908
        • Not yet recruiting
        • Hospital Duran i Reynals. Institut Catala d'Oncologia
        • Contact:
          • Eva Domingo Domenech, MD, PhD
    • Barcelona
      • Carretera De Canyet, Barcelona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias i Pujol-ICO Badalona
        • Contact:
          • Miriam Moreno Velazquez, MD, PhD
      • Passeig De La Vall d'Hebron, 119-129, Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
          • Cecilia Carpio, MD, PhD
    • C. De Villarroel, 170
      • Barcelona, C. De Villarroel, 170, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Carmen Martinez Munoz, MD, PhD
    • Calle Del Dr. Esquerdo
      • Madrid, Calle Del Dr. Esquerdo, Spain, 28007
        • Not yet recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
          • Mariana Bastos-Oreiro, MD, PhD
    • Ctra. De Colmenar Viejo Km. 9,100
      • Madrid, Ctra. De Colmenar Viejo Km. 9,100, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
          • Francisco Javier Lopez Jimenez, MD, PhD
    • P.º De San Vicente, 58
      • Salamanca, P.º De San Vicente, 58, Spain, 37007
        • Not yet recruiting
        • Hospital Universitario de Salamanca
        • Contact:
          • Roman Garcia Sanz, MD, PhD
    • Santander
      • Av. De Valdecilla, 25, Santander, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Javier Nuñez Cespedes, MD, PhD
    • Sevilla
      • Av. Manuel Siurot, Sevilla, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Jorge Rodríguez Garcia, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
Nivolumab, total dose 5760 mg milligram
Drug: Nivolumab 10 MG/ML
Nivolumab, 100 mg, 10 mg/ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy exploration in terms of 3-Y PFS of chemotherapy alone
Time Frame: During follow-up (36 months) after the end of treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy exploration in terms of 3-Y PFS of chemotherapy plus Nivolumab
Time Frame: During follow-up (36 months) after the end of treatment
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
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
Time Frame: During follow-up (36 months) after the end of treatment
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
During follow-up (36 months) after the end of treatment
Safety exploration in terms of 3-Y OS of a treatment with chemotherapy alone
Time Frame: During follow-up (36 months) after the end of treatment
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
During follow-up (36 months) after the end of treatment
Evaluation the ability of cell-free DNA (cfDNA) assay
Time Frame: During follow-up (36 months) after the end of treatment
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�
During follow-up (36 months) after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Gdansk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan M Zaucha, Professor, PhD, MD, Medical University of Gdańsk
  • Principal Investigator: Andrea Gallamini, Professor, PhD, MD, Research and Clinical Innovation Department of the Lacassagne Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBK132/1/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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