Efficacy of Slow Tempo Inductions and Maintenance using Low Dose Cytarabine and Thioguanine: Single arm study.
Slow Tempo Inductions and Maintenance using Low Dose Cytarabine and Thioguanine. Single arm study of combination chemotherapy with cytarabine and thioguanine in patients with AML.
Northern Sydney local Health District
30 participants
May 17, 2013
Interventional
Conditions
Summary
The primary purpose of this trial is to evaluate the efficacy and tolerability of a 'slow tempo' chemotherapy regimen for the treatment of acute myeloid leukaemia (AML). Who is it for? You may be eligible to take part in this trial if you have newly diagnosed AML and are aged 65 or over, or are unable to undergo standard care chemotherapy; if you have untreated secondary AML or transformed AML and are aged 18yrs or over; or if you have relapsed or refractory AML are you are aged 18 or over. Study details All participants enrolled in this trial will undergo the slow tempo chemotherapy treatment regimen, which will involve 35-day cycles of induction chemotherapy until remission is achieved, followed by three 35-day cycles of consolidation chemotherapy, lastly followed by 42-day chemotherapy cycles for two years. Participants will be assessed for disease progression and for treatment side effects throughout the treatment. It is hoped that the findings from this trial will provide information on whether slow tempo chemotherapy with low dose cytarabine and thioguanine is safe, tolerable and effective in the treatment of newly diagnosed and refractory/relapsed AML.
Eligibility
Inclusion Criteria8
- Acute Myeloid leukaemia (based on WHO diagnostic criteria) with:
- a. Newly diagnosed AML with age >65yrs, or co-morbidities that are a contraindication to induction chemotherapy (that is, in the view of the treating physician, medically unsuitable for high dose chemotherapy treatment)
- b. Untreated Secondary AML or transformed AML, 18 years or above.
- c. Relapsed or refractory AML and aged >18 years
- ECOG Performance Status of 0-2
- Life expectancy of at least 3 months in relation to diseases other than AML
- If of child-bearing/fathering potential, agreeable to use permanent contraception (by oral or implantable hormones or double-barrier methods)
- Able to understand study risk and benefits, and to give informed consent
Exclusion Criteria6
- Serious hepatic disease (with serum transaminases >5x ULN)
- Serious renal disease (with serum creatinine >300mmol/L)
- Other co-morbidity, likely in the investigator's opinion to interfere with participation.
- Likely inability to comply with treatment and monitoring in the investigator's opinion.
- Existing or planned pregnancy or lactation.
- Participation in any concurrent investigational therapeutic study.
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Interventions
New diagnosed Acute Myeloid Leukaemia and Refractory/Relapsed Acute Myeloid Leukaemia Induction chemotherapy (Day1-35) Cytarabine 20mg/m2 subcutaneoulsy administered daily, Day 1-21 Thioguanine 40mg/m2 orally administered daily, Day 1-21 PEG-filgrastim 6mg administered subcutaneously on Day 8. When absolute neutrophil <1 x 109/L, then repeat PEG-filgrastim subcutaneously injection every 14 days until neutrophil >1. Repeat induction chemotherapy if bone marrow (D31-35) demonstrates residual blasts >5%. Consolidation Chemotherapy (5wk cycles from Day 1-35) Cytarabine 20mg/m2 subcutaneously administered daily, Day 1-14 Thioguanine 40mg/m2 orally administered daily, Day 1-14 PEG-filgrastim 6mg administered subcutaneously on Day 8. When absolute neutrophil <1 x 109/L. Consolidation treatment cycle should be repeated a total of 3 x every 35 days (ie. 3 x 5wk cycles) Maintenance chemotherapy (6 wk cycles from Day 1-42) Cytarabine 20mg/m2 subcutaneously administered daily, Day 1-14 Thioguanine 40mg/m2 orally administered daily, Day 1-14 Repeat cycle every 42 days (6wk cycles) for a total of 2 years. Strategies used to ensure individuals adherence to this protocol Comprehensive patient schedules are provided to each person with detailed explanations.
Locations(1)
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ACTRN12617000231347