Obinutuzumab 1000 / Gemcitabine 1000 / Oxaliplatin 100 / Glofitamab (2.5/10), diffuse large B-Non-Hodgkin Lymphoma, cycle 1

Protocol-ID: 2808 V1.0 (Short), OBIN1000/GEMC1000/OXAL100/GLOF(2,5/10), DLBCL, C1

Indication(s)

NHL, B-Cell Type, Diffuse Large Cell; ICD-10 C83.3

Protocol classification

Classification: current standard
Intensity: Standard dose
Therapy mode: Relapse therapy
Therapy intention: palliative

Cycles

Cycle length 21 days, recommended cycles: 1

Protocol sequences

STARGLO: OBIN1000/GEMC1000/OXAL100/GLOF(2,5/10), DLBCL, C1 (PID2808) -|- C2-8 (PID2809) -|- C9-12 (PID2810)

Risks

Emetogenicity (MASCC/ESMO): moderate (30-90%)
Neutropenia: high (21-40%)
Febrile Neutropenia: high (>20%)
Upper Respiratory Tract Infection: CTC AE °1-4: 9%
Neurotoxicity: CTC AE °1-4: 31%
Pneumonia: CTC AE °1-4: 13%
Cytokine Release Syndrome: CTC AE °1-2: 42%; °3: 2%
COVID-19 infection: CTC AE °1-4: 14%

Therapy

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HYD Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
1	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Obinutuzumab (d1)

2	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Gemcitabine (d2)
8	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Glofitamab (d8)

15	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Glofitamab (d15)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AE Antiemesis: Emetogenicity moderate, GRAN i.v., DEXA i.v.
Access: peripheral venous
ASCO 2015, DGHO 2016, DKG 2016, MASCC/ESMO 2016, if palonosetron not available
2	Dexamethasone	8 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Gemcitabine (d2)
2	Granisetron	1 mg	NaCl 0.9% 50 ml	i.v.	5 min	15 min before Gemcitabine (d2)
or other 5-HT3 receptor antagonist
3-4	Dexamethasone	8 mg		p.o.		1-0-0-0

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AP Allergy prophylaxis: Allergy prophylaxis Obinutuzumab and Glofitamab
Access: peripheral venous
1	Prednisolone	100 mg	NaCl 0.9% 100 ml	i.v.	15 min	90 min before Obinutuzumab (d1)
1	Paracetamol	1000 mg		p.o.		60 min before Obinutuzumab (d1)
1	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	60 min before Obinutuzumab (d1)
8	Prednisolone	100 mg	NaCl 0.9% 50 ml	i.v.	15 min	90 min before Glofitamab (d8)
8	Paracetamol	1000 mg		p.o.		60 min before Glofitamab (d8)
8	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	60 min before Glofitamab (d8)
15	Prednisolone	100 mg	NaCl 0.9% 50 ml	i.v.	15 min	90 min before Glofitamab (d15)
15	Paracetamol	1000 mg		p.o.		60 min before Glofitamab (d15)
15	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	60 min before Glofitamab (d15)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
ANTX Antineoplastic therapy: OBIN1000/GEMC1000/OXAL100/GLOF(2.5/10)
Access: peripheral venous
1	Obinutuzumab	1000 mg	NaCl 0.9% 250 ml	i.v.	4 h	Sequence
The infusion can be started at a rate of 50 mg/hr and increased in increments of 50mg/hr every 30 minutes to a maximum of 400 mg/hr.
2	Gemcitabine	1000 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	30 min	Sequence
2	Oxaliplatin	100 mg/m² BSA	Dextrose 5% 500 ml	i.v.	2 h	Sequence
8	Glofitamab	2.5 mg	NaCl 0.9% 100 ml	i.v.	4 h	Sequence
15	Glofitamab	10 mg	NaCl 0.9% 100 ml	i.v.	4 h	Sequence
In patients who have experienced Cytokine Release Syndrome at previous doses of glofitamab, the infusion duration may be extended up to 8 h.

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HW Hematopoietic growth factors: FN risk above 20%, G-CSF long-acting, pegylated
Access: - none -
Risk of febrile neutropenia (FN) >20%, ASCO 2015, DKG 2016
3	Pegfilgrastim	6 mg	subc	Bolus	24 h after Oxaliplatin (d2)
or other long-acting G-CSF

Day	Substance	Dosage	Appl.	Procedure
IP Infection prophylaxis: Pneumocystis jirovecii pneumonia
Access: - none -
(1,3,5) x 3	Cotrimoxazole	960 mg	p.o.	1-0-0-0

Substance links

Links to substances are found here.

Concomitant therapy supplements

Antihypertensive therapy should be interrupted at least 12 hours before Obinutuzumab administration and should not be restarted until at least one hour after administration, as hypotension may occur as a sign of an infusion-related reaction during the infusion. Occurrence of Cytokine Release Syndrome possible. Consider administration of Tocilizumab from grade 2 (see corresponding protocol). Observe tumor lysis syndrome risk classification according to Cairo 2010, use "Tumor lysis syndrome prophylaxis, medium risk" protocol for LDH elevation without tumor bulk. In case of LDH elevation above twice the upper limit and tumor bulk protocol use "Tumor Lysis Syndrome Prophylaxis, High Risk". CMV reactivation should be treated preventively.

References

Abramson JS, Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024 Nov 16;404(10466):1940-1954. doi: 10.1016/S0140-6736(24)01774-4. PMID: 39550172. [PMID]

Recommendations

12/2024: National Comprehensive Cancer Network

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Valid since: 03.02.2025