JPRN-jRCTs041180174
Active, not recruiting
Phase 2
Phase II study of interim FDG-PET-guided response-adapted therapy in pediatric patients with Hodgkin's lymphoma - HL-14
Koga Yuhki0 sites50 target enrollmentMarch 29, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Koga Yuhki
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) diagnosis of Hodgkin's lymphoma
- •(2\) age under 20 year old at diagnosis
- •(3\) registration at JPLSG CHM\-14 study
- •(4\) written informed consent obtained from patient and/or guardians
Exclusion Criteria
- •(1\) Cases where impaired liver, kidney and cardiac functions compromise experimental treatment
- •(2\) Patients who have been treated with anticancer drugs or radiation therapy
- •(3\) Presence of CNS degenerative lesion
- •(4\) Associated intracranial hemorrhage which hinders execution of treatment process
- •(5\) Associated infection which is difficult to control
- •(6\) Pregnant or possibility of pregnancy
- •(7\) Women who are breastfeeding
- •(8\) Past history of malignant neoplasm or multiple primary neoplasms
- •(9\) History of congenital or acquired immune deficiency syndrome
- •(10\) Any other reasons that the attending physician has deemed unsuitable
Outcomes
Primary Outcomes
Not specified
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Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II studyAdvanced stage Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10020243Term: Hodgkin's disease NECSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-000498-35-PLEuropean Organisation for Research and Treatment of Cancer (EORTC)150