MOGAMULIZUMAB-KPKC INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Care not provided by a VA or VA Community Care hematology/oncology provider
- Evidence of large cell transformation (LCT)
- Evidence of central nervous system (CNS) metastasis
- History of allogeneic or autologous hematopoietic stem cell transplant (HSCT) within past 90 days
- Plan to undergo allogeneic HSCT within the next 6 months
- Chronic or unresolved infection
- Active autoimmune disease (e.g., Graves’ disease, SLE, RA, Crohn’s, psoriasis)
- ANC < 1500 cells/mm3, platelets < 100,000 cells/mm3 (if marrow involvement, then ANC <1000 and platelets < 75,000)
- Severe hepatic impairment (Child-Pugh Class C), as drug has not been evaluated in this population
- Pregnancy (i.e., known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS)
- Relapsed or refractory disease after at least two prior courses of systemic therapy (patients received 2-5 prior treatments in MAVORIC)
- Mogamulizumab will be used as a single agent therapy (not to be given in combination with other systemic therapies)
- ECOG Performance Status 0-1 (ECOG Eastern Cooperative Oncology Group)
- Counseling provided to advise female patients of reproductive potential OR male patients and their female partners of reproductive potential to use effective contraception during treatment with mogamulizumab-kpkc and for at least 3 months following last dose of mogamulizumab-kpkc