よむ、つかう、まなぶ。
会議資料 (164 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00046.html |
| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第68回 5／25）《厚生労働省》 |
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要望番号；III➀-73
C
Mature B-cell ALL (>25% blasts in marrow) and/or CNS
disease
用法・用量
（または用法・用量に関
連のある記載箇所）
① NCCN の診療ガイドライン
(1) Group B
“PRINCIPLES OF SYSTEMIC THERAPY (BL and DLBCL)”にて、
Group B に 対 す る 寛 解 導 入 療 法 の 推 奨 レ ジ メ ン と し て ”COG
ANHL1131 (based on FAB/LMB96) Regimen B”が示されており、以下の
記載がある。
▶ Regimen B/Induction 1 & 2 R-COPADM
◊ Induction I starts on day 8 of the COP pre-phase. Note: If rituximab is
included, the first dose is given on day 6 of the pre-phase.
– In the event the patient is too ill to proceed to COPADM1, a second
COP phase may be administered.
– In the event of significant effusions or renal dysfunction on day 1,
high-dose methotrexate may be delayed to day 5 or omitted in the
context of persistent or large fluid collections.
– In the event the patient requires second COP pre-phase, the patient
should not repeat day minus 2 (day 6 of COP pre-phase)
Rituximab if already received.
◊ Induction II starts 16-21 days after the start of Induction I, as soon as
counts are recovering toward absolute neutrophil count (ANC) 750 and
platelets 75,000, resolving mucositis and clinically stable. Delays are to
be avoided. Give day minus 2 rituximab as counts start recovering.
[Dose and schedule]
Rituximab: 375 mg/m²/day on day minus 2 (day 6 of COP pre-phase for
R-COPADM1 [can be administered prior to response
assessment]) and day 1
▶ Regimen B/Consolidation 1 & 2 R-CYM (rituximab, cytarabine,
methotrexate)
◊ Consolidation cycles start 16-21 days after the start of the previous cycle,
as soon as counts are recovering toward ANC 750 and platelets 75,000,
resolving mucositis and clinically stable. If not in remission after CYM 1,
change to Group C1, CNS-negative starting with R-CYVE 1 (rituximab,
cytarabine, etoposide).
[Dose and schedule]
Rituximab: 375 mg/m²/day on day 1
28
164/370
C
Mature B-cell ALL (>25% blasts in marrow) and/or CNS
disease
用法・用量
（または用法・用量に関
連のある記載箇所）
① NCCN の診療ガイドライン
(1) Group B
“PRINCIPLES OF SYSTEMIC THERAPY (BL and DLBCL)”にて、
Group B に 対 す る 寛 解 導 入 療 法 の 推 奨 レ ジ メ ン と し て ”COG
ANHL1131 (based on FAB/LMB96) Regimen B”が示されており、以下の
記載がある。
▶ Regimen B/Induction 1 & 2 R-COPADM
◊ Induction I starts on day 8 of the COP pre-phase. Note: If rituximab is
included, the first dose is given on day 6 of the pre-phase.
– In the event the patient is too ill to proceed to COPADM1, a second
COP phase may be administered.
– In the event of significant effusions or renal dysfunction on day 1,
high-dose methotrexate may be delayed to day 5 or omitted in the
context of persistent or large fluid collections.
– In the event the patient requires second COP pre-phase, the patient
should not repeat day minus 2 (day 6 of COP pre-phase)
Rituximab if already received.
◊ Induction II starts 16-21 days after the start of Induction I, as soon as
counts are recovering toward absolute neutrophil count (ANC) 750 and
platelets 75,000, resolving mucositis and clinically stable. Delays are to
be avoided. Give day minus 2 rituximab as counts start recovering.
[Dose and schedule]
Rituximab: 375 mg/m²/day on day minus 2 (day 6 of COP pre-phase for
R-COPADM1 [can be administered prior to response
assessment]) and day 1
▶ Regimen B/Consolidation 1 & 2 R-CYM (rituximab, cytarabine,
methotrexate)
◊ Consolidation cycles start 16-21 days after the start of the previous cycle,
as soon as counts are recovering toward ANC 750 and platelets 75,000,
resolving mucositis and clinically stable. If not in remission after CYM 1,
change to Group C1, CNS-negative starting with R-CYVE 1 (rituximab,
cytarabine, etoposide).
[Dose and schedule]
Rituximab: 375 mg/m²/day on day 1
28
164/370