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

Phase 1

• Conditions: Early stage classical Hodgkin Lymphoma (cHL) without bulky lesions and constitutional symptoms; MedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002382-33-PL
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-22
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Male or female patients aged 18-70.
2. Treatment-naïve, classical HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A);
3. 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];
4. ECOG performance status 0-2
5. Hemoglobin must be > 8 gr./dL
6. Absolute neutrophil count = 1,000/µL
7. Platelet count = 100,000/µL
8. Voluntary written consent to take part to the study
9. Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute
10. Total bilirubin must be < 2.0 x the upper limit of normal (ULN) unless known Gilbert syndrome
11. ALT or AST must be < 3 x the upper limit of normal.
12. 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.
13. Male patients should agree to practice barrier contraception or to practice abstinence

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1. Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma;
2. Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters);
3. B symptoms;
4. Extra nodal site involved by disease;
5. 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;
6. Uncompensated diabetes mellitus requiring insulin therapy;
7. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol;
8. Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA;
9. Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA;
10. Severely impaired, lung and renal function;
11. 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;
12. Active autoimmune disorder in treatment with immunosuppressive drugs
13. A left-ventricular ejection fraction < 50%;
14. Myocardial infarction within 2 years of study entry.
15.Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified