Leukaemia and Myeloid Neoplasms SACT Regimens

The information contained in these regimens is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. The treatment regimen to be used should take into account factors such as histology, molecular pathology, age, performance status, co-morbidities and the patient’s preference.Each treatment regimen has advantages and disadvantages, and there may be more than one good option. In addition, treatment choices can change over time as more evidence becomes available. Use of these documents is the responsibly of the prescribing clinician and is subject to the HSE.ie terms of use.

Please email any comments or feedback on these regimens to oncologydrugs@cancercontrol.ie.

See Acute Leukaemia (AML, APL, ALL, Burkitt’s Leukaemia)
See Myeloid Neoplasms (CML, MDS, PV, PMF)

For information on open clinical trials please refer to the Cancer Trials Ireland website here and also to basket trials here.

Acute Leukaemia (AML, APL, ALL, Burkitt’s Leukaemia)

Regimen Name	Indication
azaCITIDine (Oral) Monotherapy Regimen	00818a Maintenance treatment in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation (HSCT).
azaCITIDine75mg/m2 5-2-2 Therapy Regimen	00287d Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to WHO classification.
azaCITIDine 100mg/m² 5-day Therapy Regimen	00288d Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to WHO classification.
Intermediate Dose Cytarabine Therapy Regimen	00364a Consolidation chemotherapy for the treatment of patients Acute Myeloid Leukaemia (AML)
High Dose Cytarabine Therapy Regimen	00365a Consolidation chemotherapy for the treatment of patients with Acute Myeloid Leukaemia (AML)
DA(60/100) 3+10: Course 1 Induction Therapy (AML-17) Regimen	00359a Induction chemotherapy regimen for the treatment of patients with de novo or secondary Acute Myeloid Leukaemia (AML)
DA (50/100) (3+8) Course 2 Induction Therapy (AML-17) Regimen	00360a Induction chemotherapy regimen for the treatment of patients with de novo or secondary Acute Myeloid Leukaemia (AML)
Decitabine Monotherapy – AML (28 day cycle) Regimen	00231a Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary AML, according to the WHO classification, who are not candidates for standard induction chemotherapy.
FLAG Therapy Regimen	00363a Treatment of Acute Myeloid Leukaemia (AML) in patients unsuitable for treatment with idarubicin or as consolidation post FLAG-Ida. 00363c Salvage regimen for patients with relapsed/refractory acute leukaemia.
FLAG: Ida 8mg/m² Therapy Regimen	00362a Induction of chemotherapy regimen for the treatment of patients with de novo, secondary Acute Myeloid Leukaemia (AML), or biphenotypic leukaemia. 00362c Salvage regimen for patients with relapsed/refractory acute leukaemia
Gemtuzumab Ozogamicin, DAUNOrubicin and Cytarabine Therapy (AML induction) Regimen	00612a Gemtuzumab ozogamicin is indicated for combination therapy with DAUNOrubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive Acute Myeloid Leukaemia (AML), except acute promyeloytic leukaemia
Midostaurin Maintenance Therapy Regimen	00661a Midostaurin is indicated as single agent maintenance therapy for adult patients with FLT3 mutation positive acute myeloid leukaemia (AML) in complete response after completion of induction and consolidation chemotherapy
Midostaurin (DAUNOrubicin and Cytarabine) Induction Therapy Regimen	00682a Midostaurin is indicated in combination with standard DAUNOrubicin and cytarabine induction chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive
Midostaurin and Intermediate Dose Cytarabine Consolidation Therapy Regimen	00683a Midostaurin is indicated in combination with intermediate dose cytarabine consolidation consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive.
Vyxeos liposomal® DAUNOrubicin and Cytarabine Induction Therapy Regimen	00613a For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
Vyxeos liposomal® DAUNOrubicin and Cytarabine Consolidation Therapy Regimen	00618a For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
Tretinoin (ATRA) with Arsenic Trioxide (ATO) Induction Therapy Regimen	00356a Treatment of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC count ≤ 10x109 /L) 00356b Treatment of adult patients with relapsed or refractory APL after ATRA/chemotherapy.
Tretinoin (ATRA) with Arsenic Trioxide (ATO) Consolidation Therapy Regimen	00357a Treatment of patients with low to intermediate risk Acute Promyelocytic Leukaemia (APL) with haematological complete remission (CR) after induction treatment with tretinoin (ATRA) and arsenic trioxide (Ref NCCP Protocol 00356).
Tretinoin (ATRA)IDArubicin (PETHEMA AIDA) Induction Therapy:High Risk Regimen	00366a Treatment of patients with newly diagnosed high risk Acute Promyelocytic Leukaemia (APL)
Blinatumomab Therapy Regimen	00538a Treatment of adult patients with relapsed or refractory B cell precursor (BCP) Philadelphia chromosome negative acute lymphoblastic leukaemia (ALL) who have received no prior salvage treatment for relapsed/refractory (R/R) disease and are considered eligible for transplant (i.e. as a bridge-to-transplant).
Blinatumomab Therapy (ALL with MRD ≥ 0.1%) Regimen	00590a As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Inotuzumab ozogamicin Monotherapy Regimen	00537a Monotherapy for the treatment of adults with relapsed or refractory CD22- positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
PONATinib Therapy Regimen	00302a Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Venetoclax and azaCITIDine Therapy Regimen	00852a Venetoclax in combination with azaCITIDine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy

Regimen Name

Indication

azaCITIDine (Oral) Monotherapy

Leukaemia and Myeloid Neoplasms SACT Regimens

Acute Leukaemia (AML, APL, ALL, Burkitt’s Leukaemia)

Myeloid Neoplasms (CML, MDS, PV, PMF)