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)