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

Protocol-ID: 2808 V1.0 (Complete), 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

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

HYD
Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Balanced Crystalloid Solution 500 ml   i.v.60 min60 min before Obinutuzumab (d1) 
2 Balanced Crystalloid Solution 500 ml   i.v.60 min60 min before Gemcitabine (d2) 
8 Balanced Crystalloid Solution 500 ml   i.v.60 min60 min before Glofitamab (d8) 
15 Balanced Crystalloid Solution 500 ml   i.v.60 min60 min before Glofitamab (d15) 
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
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
2 Dexamethasone 8 mg NaCl 0.9% 50 ml i.v.5 min30 min before Gemcitabine (d2) 
2 Granisetron 1 mg NaCl 0.9% 50 ml i.v.5 min15 min before Gemcitabine (d2) 
or other 5-HT3 receptor antagonist
3-4 Dexamethasone 8 mg  p.o. 1-0-0-0 
AP
Allergy prophylaxis: Allergy prophylaxis Obinutuzumab and Glofitamab
Access: peripheral venous
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Prednisolone 100 mg NaCl 0.9% 100 ml i.v.15 min90 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 min60 min before Obinutuzumab (d1) 
8 Prednisolone 100 mg NaCl 0.9% 50 ml i.v.15 min90 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 min60 min before Glofitamab (d8) 
15 Prednisolone 100 mg NaCl 0.9% 50 ml i.v.15 min90 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 min60 min before Glofitamab (d15) 
ANTX
Antineoplastic therapy: OBIN1000/GEMC1000/OXAL100/GLOF(2.5/10)
Access: peripheral venous
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Obinutuzumab 1000 mg NaCl 0.9% 250 ml i.v.4 hSequence 
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 minSequence 
2 Oxaliplatin 100 mg/m² BSA Dextrose 5% 500 ml i.v.2 hSequence 
8 Glofitamab 2.5 mg NaCl 0.9% 100 ml i.v.4 hSequence 
15 Glofitamab 10 mg NaCl 0.9% 100 ml i.v.4 hSequence 
In patients who have experienced Cytokine Release Syndrome at previous doses of glofitamab, the infusion duration may be extended up to 8 h.
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
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
3 Pegfilgrastim 6 mg   subcBolus24 h after Oxaliplatin (d2) 
or other long-acting G-CSF
IP
Infection prophylaxis: Pneumocystis jirovecii pneumonia
Access: - none -
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
(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.

Cycle diagram

Hydration: Balanced Crystalloid Solution

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Balanced Crystalloid Solution (i.v.)                     
Balanced Crystalloid Solution (i.v.)                     
Balanced Crystalloid Solution (i.v.)                     
Balanced Crystalloid Solution (i.v.)                     

Antiemesis: Emetogenicity moderate, GRAN i.v., DEXA i.v.

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Dexamethasone (i.v.)                     
Granisetron (i.v.)                     
Dexamethasone (p.o.)                     

Allergy prophylaxis: Allergy prophylaxis Obinutuzumab and Glofitamab

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Prednisolone (i.v.)                     
Paracetamol (p.o.)                     
Dimetinden (i.v.)                     
Prednisolone (i.v.)                     
Paracetamol (p.o.)                     
Dimetinden (i.v.)                     
Prednisolone (i.v.)                     
Paracetamol (p.o.)                     
Dimetinden (i.v.)                     

Antineoplastic therapy: OBIN1000/GEMC1000/OXAL100/GLOF(2.5/10)

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Obinutuzumab (i.v.)                     
Gemcitabine (i.v.)                     
Oxaliplatin (i.v.)                     
Glofitamab (i.v.)                     
Glofitamab (i.v.)                     

Hematopoietic growth factors: FN risk above 20%, G-CSF long-acting, pegylated

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Pegfilgrastim (subc)                     

Infection prophylaxis: Pneumocystis jirovecii pneumonia

Week 1 / dWeek 2 / dWeek 3 / d
Substance 123456789101112131415161718192021
Cotrimoxazole (p.o.)                     

Cycles

Cycle length 21 days, recommended cycles: 1

Controls:

  • Blood count: on day 1 and subsequently weekly
  • HIV-1, Herpes simplex, Varicella zoster, Cytomegalovirus, EBV, Hepatitis B (HBV) Test: HBsAg, anti-HBc; Hepatitis C (HCV) CMV-IgG and IgM
  • Vaccination status COVID-19, influenza, pneumococci (CAVE: exclusion of failure of specific antibody formation, PSAF), herpes zoster
  • IgG regularly under therapy
  • Echocardiography, ECG especially in patients with mediastinal involvement. Tumor flare possible.
  • Day 1: CMV (cytomegalovirus) PCR-quantitative: in case of seropositivity before therapy, during the course in case of suspected risk of infection and closely when CMV replication is detected
  • Day 1,8,15: Uric acid, Crea, GFR, LDH, Na+, K+, Ca2+, Mg2+, PO42-.
  • Day 1,8,15: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase
  • Day 8,9,15,16: Pulse
  • Day 8,9,15,16: Blood pressure Every 8 hours
  • Day 8,9,15,16: Body temperature Every 8 hours
  • Day 8,9,15,16: Oxygen saturation Every 8 hours
  • Day 8,9,15,16: Neurostatus according to ICE scoring system

Original indication

Relapsed and refractory DLBCL, not suitable for transplantation ECOG 0-1

Original author

Abramson JS (2024)

Origin

Massachusetts General Hospital Cancer Center, Boston, MA, USA, STARGLO trial

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

Status

Valid since 2025-02-03, Version 1.0, last updated 2025-12-02

Last modification: V1.0: Dosing and durations according to the summary of product characteristics.

Important notice

The copyrighted protocols are treatment recommendations. The information contained in this compilation on cytostatic drugs, concomitant medication and other therapeutic procedures, as well as dosage and application information, is continuously reviewed with all due care by the authors and editors involved. Nevertheless, the publishers and authors do not assume any liability for the correctness - also with regard to possible printing errors.

The protocols may not be changed in terms of content. Any further use of the protocols in physical or non-physical form, such as copying, distribution, disclosure, export to other media, or publication, even in excerpt form, is not permitted.

Diagnosis, indication for therapy and treatment of malignant diseases must be carried out in each individual case by the hematologist and oncologist on his or her own responsibility. The treating physician is obligated to this personal responsibility to weigh in each case before a diagnostic or therapeutic measure, indication, contraindications, dosage and application under consideration of the specialized information or other documents of the manufacturers. This applies in particular to rarely used preparations or preparations that are new to the market.

The publishers and authors assume no liability for the accuracy of the contents. The application is at the own responsibility of the treating physician. ©Onkopti.