Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome
Conditions
Interventions
Trade Name: Gemtuzumab Ozogamicin (Mylotarg)
Product Name: Mylotarg
Product Code: Gemtuzumab Ozogamicin
Pharmaceutical Form: Powder for solution for infusion
Product Name: Vosaroxin
Pharmaceutical Fo
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts). They are considered suitable for intensive chemotherapy. They should normally be under the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option. Patients must have liver function tests within twice the upper limit of the normal local range to receive Mylotarg in course 2 for the Core Binding Factor Leukaemia subset. Women of child-bearing potential (ie women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive method (abstinence, intrauterine device (IUD) and must have a negative pregnancy test within 2 weeks of trial entry. Pregnant or nursing patients are excluded. Male Patients with partners of childbearing potential must agree to use effective contraception during the study period and a period of 3 months after the last dose of study drug.. They have given written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.] They are in blast transformation of chronic myeloid leukaemia (CML). Have a LV ejection fraction of <45% (such patients can be placed on the D(60)A arm. They have a concurrent active malignancy. They are pregnant or lactating The physician and patient consider that intensive therapy is not an appropriate treatment option. (Such patients should be considered for current NCRI trial for older less fit patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare: Two induction chemotherapy schedules (namely D(90)A versus D(60)A , given in course 1), in each case followed by D(50)A as course 2 in both arms. To compare a total of three versus four courses of treatment in total, comparing one versus two courses of HD Ara-C in consolidation In high risk patients to compare novel treatments, Flag-Vosa vs standard FLAG-Ida. In highrisk patients, to evaluate the value of allogeniec stem cell transplantation (SCT), whether standard allogeneic (allo-SCT) or non-myeloblative "mini" allogeneic (mini-SCT) To assess the clinical value of minimal residual disease monitoring (MRD) for patient overall survival;Secondary Objective: The relevance of the molecular and immunophenotypic detection of minimal residual disease The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission. Store excess diagnostic material for future research ;Primary end point(s): Complete remission (CR) achievement and reasons for failure (for induction questions). Duration of remission, relapse rates and deaths in first CR. Overall survival. Toxicity, both haematological and non-haematological Quality of life for patients in the disease monitoring randomisation Supportive care requirements (and other aspects of health economics | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The relevance of the molecular and immunophenotypic detection of minimal residual disease. The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission. To store excess diagnostic material for future research. | — |
Countries
Denmark, Ireland, United Kingdom
Outcome results
None listed