We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NBK132/1/2020
Previous Study | Return to List | Next Study

Radiation Free Chemotherapy for Early Hodgkin Lymphoma (RAFTING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04866654
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Gdansk

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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Nivolumab 10 MG/ML Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : July 2, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Study group
Nivolumab, total dose 5760 mg milligram
Drug: Nivolumab 10 MG/ML
Nivolumab, 100 mg, 10 mg/ml




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  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 [ 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

  3. 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

  4. 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�



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866654


Contacts
Layout table for location contacts
Contact: Jan M Zaucha, Professor, PhD, MD 58 584 43 40 ext 0048 jzaucha@gumed.edu.pl
Contact: Marta Bednarek, PhD 58 349 18 85 ext 0048 marta.bednarek@gumed.edu.pl

Locations
Show Show 27 study locations
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT04866654    
Other Study ID Numbers: NBK132/1/2020
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action