Status:
RECRUITING
Radiation Free Chemotherapy for Early Hodgkin Lymphoma
Lead Sponsor:
Medical University of Gdansk
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 dise...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04866654
Start Date
March 4 2021
End Date
July 2 2026
Last Update
August 12 2021
Active Locations (27)
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1
Hematology Department IRCCS Policlinico San Matteo
Pavia, P.le Golgi 19, Italy, 27100
2
Ospedale Papa Giovanni XXIII
Bergamo, Piazza OMS, 1, Italy, 24127
3
Istituto Europeo di Oncologia
Milan, Via Giuseppe Ripamonti 435, Italy, 20141
4
Hematology Department Azienda Ospedaliera S. Croce e Carle
Cuneo, Via Michele Coppino, 26, Italy, 12100