Select ongoing or planned clinical trials for newly diagnosed older HL patients
| Trial title . | Trial phase . | Study number . | Disease stage . | GA-based inclusion/ GA-directed therapy . | Study design . |
|---|---|---|---|---|---|
| Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma (INDIE) | 2 | NCT04837859 | IA-IIB | Yes (CIRS-G)/no | 2 cycles tislelizumab; PET neg: 4 cycles tislelizumab +30 gy ISRT; PET pos: 4 cycles T-AVD +30 gy ISRT |
| Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin Lymphoma (RATiFY) | 2 | NCT05627115 | I-IV | No/no | 3 cycles tislelizumab; PET neg: 2 cycles T +/- RT followed by tislelizumab until PD or toxicity for fav ES or 2-4 cycles T+AVD +/- RT for unfav ES and AS; PET pos: 4-6 cycles T+AVD +/- RT for ES and AS |
| Fitness-Adapted, Pembrolizumab-Based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above | 2 | NCT05404945 | II-IV | Yes/yes (CIRS-G + ADLs) | Pembro + BV followed by repeat GA/ fitness; fit induction: 3 cycles Pembro q6w + 4 cycles AVD; unfit induction: 3 cycles Pembro q6w + 3 cycles BV; consolidation for all: Pembro +2 doses BV |
| A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-cell Lymphoma (PTCL) | 2 | NCT01716806 | II-IV | Yes/yes (CIRS-G + ADLs) | Cohorts E and F: single-agent BV for patients unsuitable or unfit for initial conventional combination chemotherapy by GA (ie, CIRS-G ≥10 and/or loss of any instrumental ADL) |
| BrEPEM-LH-22017 for Older Patients With Untreated Hodgkin Lymphoma (HL) | 1/2 | NCT03576378 | IIB-IV | No/no | 6 cycles BV-EPEM |
| HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD (elderly extension) | 2 | NCT02661503 | IIB with LMM or EN, III/IV | Yes (CIRS-G)/no | 2 cycles BrECADD; PET neg: 2 cycles BrECADD; PET pos: BrECADD 4 cycles +/- RT |
| Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (S1826)* | 3 | NCT03907488 | III/IV | No/no | 6 cycles Nivo + AVD vs 6 cycles BV + AVD |
| Trial title . | Trial phase . | Study number . | Disease stage . | GA-based inclusion/ GA-directed therapy . | Study design . |
|---|---|---|---|---|---|
| Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma (INDIE) | 2 | NCT04837859 | IA-IIB | Yes (CIRS-G)/no | 2 cycles tislelizumab; PET neg: 4 cycles tislelizumab +30 gy ISRT; PET pos: 4 cycles T-AVD +30 gy ISRT |
| Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin Lymphoma (RATiFY) | 2 | NCT05627115 | I-IV | No/no | 3 cycles tislelizumab; PET neg: 2 cycles T +/- RT followed by tislelizumab until PD or toxicity for fav ES or 2-4 cycles T+AVD +/- RT for unfav ES and AS; PET pos: 4-6 cycles T+AVD +/- RT for ES and AS |
| Fitness-Adapted, Pembrolizumab-Based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above | 2 | NCT05404945 | II-IV | Yes/yes (CIRS-G + ADLs) | Pembro + BV followed by repeat GA/ fitness; fit induction: 3 cycles Pembro q6w + 4 cycles AVD; unfit induction: 3 cycles Pembro q6w + 3 cycles BV; consolidation for all: Pembro +2 doses BV |
| A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-cell Lymphoma (PTCL) | 2 | NCT01716806 | II-IV | Yes/yes (CIRS-G + ADLs) | Cohorts E and F: single-agent BV for patients unsuitable or unfit for initial conventional combination chemotherapy by GA (ie, CIRS-G ≥10 and/or loss of any instrumental ADL) |
| BrEPEM-LH-22017 for Older Patients With Untreated Hodgkin Lymphoma (HL) | 1/2 | NCT03576378 | IIB-IV | No/no | 6 cycles BV-EPEM |
| HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD (elderly extension) | 2 | NCT02661503 | IIB with LMM or EN, III/IV | Yes (CIRS-G)/no | 2 cycles BrECADD; PET neg: 2 cycles BrECADD; PET pos: BrECADD 4 cycles +/- RT |
| Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (S1826)* | 3 | NCT03907488 | III/IV | No/no | 6 cycles Nivo + AVD vs 6 cycles BV + AVD |
Approximately 10% of patients in the study population were ages 60 years and above.
ADL, activities of daily living; AVD, adriamycin, vinblastine, dacarbazine; AS, advanced stage disease; BEACOPP, bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone; BrECADD, brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone; BV, brentuximab vedotin; CIRS-G, cumulative illness rating score-geriatric; EN, extranodal disease; EPEM, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone; ES, early-stage disease; fav, favorable; GA, geriatric assessment; gy, gray; ISRT, involved site radiation therapy; LMM, large mediastinal mass; neg, negative; Nivo, nivolumab; PD, progressive disease; Pembro, pembrolizumab; PET, positron emission tomography; pos, positive; q3w, every 3 weeks; q6w, every 6 weeks; RT, radiation therapy; T, tislelizumab; unfav, unfavorable.