Optimizing Frontline Therapy for DLBCL in Older Adults: A GLOfitamab-based, Response-adapted, Window-stYle Study (GLORY)
Memorial Sloan Kettering Cancer Center
Summary
The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).
Eligibility
- Age range
- 65–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi) 2. Age ≥80 years with any fitness level 3. Pathologically confirmed DLBCL, HGBCL or transformed lymphoma 4. No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible) 5. Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1) 6. Any IPI score (Appendix 1) 7. Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan. 8. Must have at least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension…
Interventions
- DrugGlofitamab
C1D8 2.5 mg iv; C1D15 10 mg iv; C2D1-onwards: 30 mg iv, every 3 weeks
- DrugPolatuzumab
1.8 mg/kg iv C1D1 onwards, every 3 weeks
- DrugRituximab
375 mg/m2 iv D1
- DrugCyclophosphamide
400 mg/m2 iv D1
- DrugDoxorubicin
25 mg/m2 iv D1
- DrugObinutuzumab:
1000 mg iv C1D1 (7 days prior to glofitamab administration) single dose
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York