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Leukaemia and Myeloid Neoplasms SACT Regimens

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

Avapritinib Monotherapy

Regimen

Indication

00937a

As monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy

azaCITIDine (Oral) Monotherapy

Regimen

Indication

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

Indication

00287d

Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to WHO classification.

00287e

AML with > 30% marrow blasts according to the WHO classification

azaCITIDine100mg/m2 5 day Therapy

Regimen

Indication

00288d

Acute myeloid leukaemia (AML) with 20-30% blasts and multilineage dysplasia, according to WHO classification.

00288e

AML with > 30% marrow blasts according to the WHO classification

Intermediate Dose Cytarabine Therapy

Regimen

Indication

00364a

Consolidation therapy for the treatment of patients Acute Myeloid Leukaemia (AML)

High Dose Cytarabine Therapy

Regimen

Indication

00365a

Consolidation therapy for the treatment of patients with Acute Myeloid Leukaemia (AML)

Intrathecal Cytarabine 50mg

Regimen

Indication

00870a

Central Nervous System (CNS) prophylaxis and treatment in patients with Acute Myeloid Leukaemia (AML)

00870b

CNS treatment in patients with Acute Lymphoblastic Leukaemia (ALL)

Intrathecal Cytarabine 70mg

Regimen

Indication

00871a

Central Nervous System (CNS) prophylaxis and treatment in patients with Acute Myeloid Leukaemia (AML)

00871b

CNS treatment in patients with Acute Lymphoblastic Leukaemia (ALL)

DA(60/100) (3+10) Course 1 Induction Therapy (AML-17)

Regimen

Indication

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

Indication

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

Indication

00231a

Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the WHO classification, who are not candidates for standard induction chemotherapy.

FLAG Therapy

Regimen

Indication

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

Indication

00362a

Induction 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 in combination with DAUNOrubicin and cytarabine Therapy (AML indication)

Regimen

Indication

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 Leukemia (AML), except acute promyelocytic leukaemia

Gilteritinib Therapy

Regimen

Indication

00684a

As monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

Hydroxycarbamide Therapy

Regimen

Indication

00581b

Treatment of leucocytosis in AML and CML

Hyper CVAD (ALL) Therapy - Part A

Regimen

Indication

00824a

Treatment of adult patients ≥ 25 years with Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

riTUXimab Hyper CVAD (ALL) Therapy - Part A

Regimen

Indication

00825a

Treatment of adult patients ≥ 25 years with CD20 positive, Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

Hyper CVAD (ALL) Therapy - Part B (Patients ≤ 60 years)

Regimen

Indication

00826a

Treatment of adult patients 25-60 years with Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

Hyper CVAD (ALL) Therapy - Part B (Patients > 60 years)

Regimen

Indication

00932a

Treatment of adult patients > 60 years with Philadephia chromosome (Ph) negative acute lymphoblastic leukaemia

riTUXimab Hyper CVAD (ALL) Therapy - Part B (Patients ≤ 60 years)

Regimen

Indication

00827a

Treatment of adult patients 25-60 years with CD20 positive, Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

riTUXimab Hyper CVAD (ALL) Therapy - Part B (Patients > 60 years)

Regimen

Indication

00933a

Treatment of adult patients > 60 years with CD20 positive, Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

Hyper CVAD (ALL) Maintenance Therapy (POMP)

Regimen

Indication

00912a

Maintenance therapy for adult patients ≥ 25 years with Philadelphia chromosome (Ph) negative acute lymphoblastic leukaemia

Intrathecal Methotrexate for haematological malignancies

Regimen

Indication

00869a

Central Nervous System (CNS) prophylaxis and treatment in patients with Acute Myeloid Leukaemia (AML)

00869b

CNS treatment in patients with Acute Lymphoblastic Leukaemia (ALL)

Midostaurin Maintenance Therapy

Regimen

Indication

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

Indication

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 (Intermediate Dose Cytarabine) Consolidation Therapy

Regimen

Indication

00683a

Midostaurin is indicated in combination with intermediate dose cytarabine 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

Indication

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

Indication

00618a

For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)

Triple Intrathecal Therapy

Regimen

Indication

00873a

Triple Intrathecal Therapy for treatment of Central Nervous System (CNS) disease in patients with Acute Lymphoblastic Leukaemia.

00873b

Treatment of Central Nervous System (CNS) disease in patients with Acute Myeloid Leukaemia (AML)

Tretinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy

Regimen

Indication

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

Indication

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

Indication

00366a

Treatment of patients with newly diagnosed high risk Acute Promyelocytic Leukaemia (APL)

Triple Intrathecal Therapy

Regimen

Indication

00873a

Triple Intrathecal Therapy for treatment of Central Nervous System (CNS) disease in patients with Acute Lymphoblastic Leukaemia.

00873b

Treatment of Central Nervous System (CNS) disease in patients with Acute Myeloid Leukaemia (AML)

Blinatumomab Therapy

Regimen

Indication

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

Indication

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

Indication

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

Indication

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.

Quizartinib, DAUNOrubicin and Cytarabine Induction Therapy

Regimen

Indication

00886a

Quizartinib in combination with standard DAUNOrubicin and cytarabine induction chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive.

Quizartinib and Intermediate Dose Cytarabine Consolidation Therapy

Regimen

Indication

00887a

Quizartinib in combination with cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive.

Quizartinib, IDArubicin and Cytarabine Induction Therapy

Regimen

Indication

00891a

Quizartinib in combination with standard IDArubicin and cytarabine induction chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive

Quizartinib Maintenance Therapy

Regimen

Indication

00888a

As monotherapy for the maintenance treatment of adult patients with FLT3-ITD mutation positive acute myeloid leukaemia (AML) in complete response after completion of induction and consolidation chemotherapy.

UKALL14 Phase 1 Standard Induction Therapy

Regimen

Indication

00874a

Induction of remission in newly diagnosed, previously untreated adult acute lymphoblastic leukaemia (ALL) patients (aged 25–65 years) treated on UKALL14-protocol.

UKALL14 Phase 2 Standard Induction Therapy

Regimen

Indication

00875a

Induction of remission in newly diagnosed previously untreated Adult Acute Lymphoblastic Leukaemia (ALL) patients (aged 25–65 years) treated on UKALL14-protocol following Phase 1 Induction Therapy

UKALL 14 Intensification/CNS Prophylaxis Therapy

Regimen

Indication

00876a

Treatment of adult patients (aged 25–65 years) with newly diagnosed, previously untreated acute lymphoblastic leukaemia (ALL) following Phase 2 Induction Therapy

UKALL14v12 Consolidation Phase Cycle 1

Regimen

Indication

00877a

Treatment of adult patients (aged 25–65 years) with newly diagnosed, previously untreated acute lymphoblastic leukaemia (ALL) treated on UKALL14-protocol who are in remission but not eligible for allogeneic transplantation following treatment with Intensification/CNS Prophylaxis regimen

UKALL14v12 Consolidation Phase Cycle 2 and 4

Regimen

Indication

00878a

Treatment of adult patients(aged 25–65 years) with newly diagnosed, previously untreated acute lymphoblastic leukaemia (ALL) treated on UKALL14-protocol who are in remission but not eligible for allogeneic transplantation following treatment with Consolidation Phase 1 (for Cycle 2) and Consolidation Phase 3 (for Cycle 4)

UKALL14v12 Consolidation Phase Cycle 3

Regimen

Indication

00879a

Treatment of adult patients (aged 25–65 years) with newly diagnosed, previously untreated Acute Lymphoblastic Leukaemia (ALL) treated on UKALL14- protocol who are in remission but not eligible for allogeneic transplantation following treatment with Consolidation Phase 2

UKALL14v12 Maintenance Therapy

Regimen

Indication

00881a

Treatment of adult patients (aged 25–65 years) with newly diagnosed, previously untreated Acute Lymphoblastic Leukaemia (ALL) treated on UKALL14- protocol who are in remission but not eligible for allogeneic transplantation following treatment with Consolidation Phase Cycle 4

Venetoclax and azaCITIDine Therapy

Regimen

Indication

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

Myeloid Neoplasms (CML, MDS, PV, PMF)

Asciminib Therapy

Regimen

Indication

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).

azaCITIDine75mg/m2 5-2-2 Therapy

Regimen

Indication

00287c

Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder

azaCITIDine100mg/m2 5-day Therapy

Regimen

Indication

00288c

Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder

Bosutinib Monotherapy

Regimen

Indication

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.

azaCITIDine75mg/m2 5-2-2 Therapy

Regimen

Indication

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).

azaCITIDine100mg/m2 5-day Therapy

Regimen

Indication

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).

FLAG Therapy

Regimen

Indication

00363b

Treatment of patients with high blast count (>10%) Myelodysplastic Syndrome in patients unsuitable for treatment with IDArubicin.

FLAG: Ida 8mg/m2 Therapy

Regimen

Indication

00362b

Treatment of patients with blast count (>10%) Myelodysplastic Syndrome

Fedratinib Therapy

Regimen

Indication

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

Hydroxycarbamide Therapy

Regimen

Indication

00581a

Treatment for patients with high risk myeloproliferative neoplasms

00581b

Treatment of leucocytosis in AML and CML

Momelotinib Therapy

Regimen

Indication

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.

PONATinib Therapy

Regimen

Indication

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.

Peginterferon alfa-2a Therapy

Regimen

Indication

00883a

As monotherapy in adults for the treatment of polycythaemia vera.

00883b

As monotherapy in adults for the treatment of essential thrombocythaemia.

00883c

As monotherapy for the treatment of primary or secondary myelofibrosis (post-essential thrombocythemia or post -polycythemia vera.

Ruxolitinib Monotherapy

Regimen

Indication

00229a

Primary myelofibrosis (chronic idiopathic myelofibrosis)

00229b

Post polycythaemia vera myelofibrosis

00229c

Post essential thrombocythaemia myelofibrosis