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Table 2 Pre-medication of patients receiving epcoritamab

From: Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial

 

Corticosteroids

Antihistamines

Antipyretics

Cycle 1

1st epcoritamab administration (priming dose)

Day 1*

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

Chlorphenamine 10 mg PO/IV (or equivalent)

Paracetamol 1000 mg PO (or equivalent)

Day 2

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 3

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 4

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

2nd epcoritamab administration (first intermediate dose)

Day 8*

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

Chlorphenamine 10 mg PO/IV (or equivalent)

Paracetamol 1000 mg PO (or equivalent)

Day 9

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 10

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 11

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

3rd epcoritamab administration

(second intermediate dose)

Day 15*

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

Chlorphenamine 10 mg IV (or equivalent)

Paracetamol 1000 mg PO (or equivalent)

Day 16

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 17

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 18

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

4th epcoritamab administration

(full dose)

Day 22*

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

Chlorphenamine 10 mg PO/IV (or equivalent)

Paracetamol 1000 mg PO (or equivalent)

Day 23

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 24

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Day 25

Dexamethasone 16 mg or Prednisolone 100 mg IV (or equivalent)

  

Cycle 2

5th epcoritamab administration

(full dose)

Day 1*

If CRS > grade 1 occurs following the 4th epcoritamab administration, 4-day consecutive corticosteroid administration is continued in from Cycle 2 onwards as required

Optional

Optional

  1. * 30 min to 2 h prior to administration of epcoritamab
  2. CRS, Cytokine release syndrome; IV, Intravenous; PO, Oral administration
  3. Granulocyte colony-stimulating factor and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia and ≥ grade 3 neutropenia, when clinically indicated or at the investigator’s discretion. In case of recurring ≥ grade 3 neutropenia, use of growth factors is mandated