Hodgkin Lymphoma
Conditions
Interventions
In this study, all patients will undergo FDG-PET examinations three times: prior to initiation of study treatment (TP1/PET1), after BV lead-in therapy (TP2/PET2), and at treatment completion or discon
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who are newly diagnosed or previously untreated and are histologically diagnosed with CD30 positive Hodgkin lymphoma (HL). (2)Patients who are under 20 years of age at the time of diagnosis. (3)Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2. Patients with PS 3 attributable to the primary disease are also eligible. (4)Patients possessing adequate function of major organs (e.g., cardiac, hepatic, renal) sufficient to receive the investigational treatment, specifically meeting all of the following laboratory requirements. Laboratory values must be obtained within 14 days prior to, and including, the date of registration: 1)Direct bilirubin 50%.) 4)Peripheral oxygen saturation > 94% on room air. Refer to the Appendix: Reference Ranges of Clinical Laboratory Tests by Sex and Age. (5)Patients who have provided written informed consent to participate in this study. In the case of minors, written informed consent must be obtained from a legally authorized representative, or from both the patient and the representative. (6)Patients who have provided informed consent for participation in the prospective study on pediatric hematologic malignancies conducted by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG), CHM-14, prior to consenting for this trial.
Exclusion criteria
Exclusion criteria: (1)Patients who have previously received chemotherapy or radiotherapy. (2)Patients with degenerative lesions of the central nervous system (CNS). (3)Patients with intracranial hemorrhage (Common Terminology Criteria for Adverse Events [CTCAE] ver. 5.0, grade > 3) that would interfere with the administration of the investigational treatment. (4)Patients with uncontrolled infections, including active tuberculosis or HIV antibody-positive cases. (5)Patients who are pregnant or may possibly be pregnant. (6)Patients who are breastfeeding. (7)Patients with a history of malignant neoplasms or with concurrent multiple malignancies. (8)Patients who are judged by the investigator to be otherwise inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Complete Remission at the End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival rate 3-year overall survival rate Rate of PET negativity after prior BV administration, with a Deauville score of 3 or less on PET2) Rate of radiation therapy after completion of treatment Rate of adverse events Rate of complications during the follow-up period | — |
Contacts
Public ContactYuhki Koga
National Hospital Organization Kyushu Cancer Center
Outcome results
None listed