Leukaemia 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.

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

Leukaemia Chemotherapy Regimens

Regimen Name	Indication
Acalabrutinib (Tablets) Monotherapy Regimen	00840a As monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy 00840b As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy
Azacitidine 75mg/m² 5-2-2 Therapy Regimen	00287a Intermediate-1 and low risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS). 00287b Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Intermediate-2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS). 00287c Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder. 00287d Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Acute myeloid leukaemia (AML) with20-30% blasts and multi-lineage dysplasia, according to WHO classification.
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).
Asciminib Therapy Regimen	00847a Treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase (CP), who have previously been treated with two or more tyrosine kinase inhibitors (TKIs).
azaCITIDine 100mg/m² 5-day Therapy Regimen	00288a Intermediate-1 and low risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS). 00288b Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Intermediate-2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS). 00288c Treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder. 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.
Bendamustine Monotherapy Regimen	00527a Treatment of patients with relapsed or refractory Chronic Lymphocytic Leukaemia (CLL)
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%
Bosutinib Monotherapy Regimen	00224a Treatment of adult patients with chronic phase, accelerated phase, and blast phase Ph+CML previously treated with one or more TKI(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Chlorambucil 10mg/m² Therapy Regimen	00411b Treatment of patients with Chronic Lymphocytic Leukaemia
Cladribine 0.14mg/day Day 1 to 5 Therapy Regimen	00402a First line treatment for adult patients with Hairy Cell Leukaemia
Cladribine 0.14mg/kg Weekly Therapy Regimen	00469a First line treatment for adult patients with Hairy Cell Leukaemia
Cladribine Weekly and riTUXimab Therapy Regimen	00534a Treatment for adult patients with relapsed or partially responsive Hairy Cell Leukaemia.
Cladribine 5 day and riTUXimab Therapy Regimen	00531a Treatment for adult patients with relapsed or partially responsive Hairy Cell Leukaemia.
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.
Fedratinib Therapy Regimen	00788a For the treatment of disease-related splenomegaly or symptoms in adult patients with: primary myelofibrosis (PMF),post polycythaemia vera myelofibrosis (PVMF) or post essential thrombocythaemia myelofibrosis (ET MF) who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib
FLAG Therapy Regimen	00363a Treatment of Acute Myeloid Leukaemia (AML) in patients unsuitable for treatment with idarubicin or as consolidation post FLAG-Ida. 00363b Treatment of patients with high blast count (>10%) Myelodysplastic Syndrome in patients unsuitable for treatment with idarubicin. 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. 00362b Treatment of patients with blast count (>10%) Myelodysplastic Syndrome 00362c Salvage regimen for patients with relapsed/refractory acute leukaemia
Fludarabine, Cyclophosamide and riTUXimab ( FC (IV) and R) Therapy Regimen	00241a Treatment of B-cell chronic lymphocytic leukaemia (CLL).
Fludarabine, Cyclophosamide and riTUXimab ( FC (Oral) and R) Therapy Regimen	00410a Treatment of B-cell chronic lymphocytic leukaemia (CLL).
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
Ibrutinib Therapy-CLL - Waldenström’s macroglobulinaemia Regimen	00296a As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. 00296b As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. 00296c As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Idelalisib and riTUXimab Therapy Regimen	00389a In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy 00389b In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies
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).
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
Momelotinib Therapy Regimen	00867a For the treatment of disease-related splenomegaly or symptoms in adult patients with: Moderate to severe anaemia who have primary myelofibrosis, Post polycythaemia vera myelofibrosis or Post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
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.
Obinutuzumab and Chlorambucil Therapy Regimen	00286a Treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
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. 00302b Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Ruxolitinib Monotherapy Regimen	The treatment of disease-related splenomegaly or symptoms in adult patients with: 00229a Primary myelofibrosis (chronic idiopathic myelofibrosis) 00229b Post polycythaemia vera myelofibrosis 00229c Post essential thrombocythaemia myelofibrosis
Tretinoin (ATRA) with Arsenic Trioxide (ATO) Induction Therapy Regimen	00356a Treatment of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) 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)
Venetoclax Monotherapy Regimen	00400a Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. 00400b Treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
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
Venetoclax and obinutuzumab Therapy Regimen	00715a In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Venetoclax and riTUXImab Therapy Regimen	00575a Venetoclax in combination with riTUXimab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy
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)

Regimen Name

Indication

Acalabrutinib (Tablets) Monotherapy