EUCTR2020-002382-33-ITActive, not recruitingPhase 1
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 - RAFTING
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medical University of Gdansk
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Male or female patients aged 18-60 years;
- •2.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);
- •3.Patients must have a histologically confirmed diagnosis of 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 must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
- •10.Total Bilirubin <2 x upper limit of normal, unless known Gilberts syndrome.
- •11.ALT or AST <3 x the upper limit of normal. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver
- •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 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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