Page 66 - 2020_02-Haematologica-web

I. Yakoub-Agha et al.
Table 1. Eligibility criteria for the selection of patients for clinical trials.
Characteristics
Age limit (NHL)
Age limit (ALL)
ECOG PS Performance Status
History of malignancy
Prior allo-HCT
Prior anti-CD19/anti-CD3 BiTE antibodies or
any other CD19 therapy
Previous CAR T-cell therapy
History of autoimmune disease
Current systemic immunosuppressive treatment
Existing or suspected fungal, bacterial, viral, or other infection
ELIANA (ALL KymriahTM)
N/A
JULIET (DLBCL KymriahTM)
≥18 years
SPC - No data are available
on children < 18 years of age
ZUMA-1 (High-grade B-cell NHL YescartaTM)
≥18 years
SPC - No data are available
on children < 18 years of age
N/A
ECOG PS of 0 or 1
No history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least
3 years
Excluded
Excluded if prior CD19 targeted therapy
Excluded
Not an exclusion criterion
Any immunosuppressive medication must be stopped more than
4 weeks prior to enrollment
EBMT recommendations
No upper age limit
Follow SPC
Comment
Decision should be based on physical condition rather than age
Ability to collect sufficient cells by apheresis can be a limiting factor in infants and small children
‘Age 3 years at the time
of screening to age 21 years at the time of initial diagnosis’
SPC- up to 25 years of age
Karnofsky (age ≥16 years) or Lansky (age <16 years) PS ≥50 at screening
No prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
Not excluded; however, excluded if grade II-IV acute or extensive chronic GvHD
Excluded
Not a contraindication as per SPC
Not applicable in trials Not in SPC
Not an exclusion criterion
Any GvHD therapy must be stopped more than 4 weeks prior to enrollment to confirm that GvHD recurrence is not observed
Active or latent HBV or HCV (test within 8 weeks
of screening) or any uncontrolled infection at screening
N/A
ECOG PS
of either
0 or 1 at screening
No previous or concurrent malignancy except adequately treated
BCC or SCC, in situ cancer of the breast
or cervix treated and without recurrence for 3 years, primary malignancy resected and in remission for more than 5 years
Excluded
Excluded
Not applicable in trials Not in SPC
Not an exclusion criterion
Any immunosuppressive medication must be stopped more than
4 weeks prior to enrollment
Uncontrolled active or latent HBV
or active HCV; Uncontrolled acute life- threatening bacterial, viral or fungal infection (e.g. blood cultures positive <72 h prior to screening)
>2 not recommended Note, however,
that real-world data with
Prognosis may be less poor if the decline
YescartaTM included patients with ECOG PS >218
Absence of history of malignancy other than carcinoma in situ (e.g. cervix, bladder, breast) unless disease- free and off therapy for at least 3 years
Not a contraindication
Not a contraindication
Not a contraindication
in PS is due to active disease
Active GvHD is listed as a reason to delay treatment in the KymriahTM and YescartaTM SPC
Further CAR T-cell therapy outside of clinical trials is to be avoided
Not recommended
in active autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression
or systemic disease-modifying agents within the last
2 years
Individualized risk-benefit assessment required
Known history of HIV,
HBV (HepBs Ag positive)
or HCV (anti-HCV); Clinically significant active infection, or currently receiving IV antibiotics or within
7 days of enrollment
Contraindication
Relative contra-indication; individualized risk-benefit assessment required
Intermittent topical, inhaled or intranasal corticosteroids are allowed
Active infection should be controlled and on treatment prior to leukapheresis
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