RecruitingPhase 2ACTRN12617000231347

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.

Sponsor

Northern Sydney local Health District

Enrollment

30 participants

Start Date

May 17, 2013

Study Type

Interventional

Conditions

Newly diagnosed Acute Myeloid Leukaemia Relapsed or Refractory Acute Myeloid Leukaemia

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a gentler chemotherapy approach — called 'slow tempo' chemotherapy — for people with acute myeloid leukaemia (AML) who are not able to tolerate standard intensive chemotherapy. Standard AML treatment is very harsh and not suitable for older or frail patients. This lower-intensity regimen uses two medications over longer treatment cycles and aims to achieve remission while being tolerable for vulnerable patients. You may be eligible if: - You have been newly diagnosed with AML and are 65 years or older, OR you have other health conditions that make standard chemotherapy too risky - You have untreated secondary or transformed AML and are 18 years or older - You have relapsed or refractory AML (the cancer came back or didn't respond to prior treatment) and are 18 years or older - Your performance status is good enough to participate (ECOG 0–2) - Your life expectancy from other illnesses is at least 3 months You may NOT be eligible if: - You have serious liver disease (very high liver enzyme levels) - You have serious kidney disease (very high creatinine) - You are pregnant or breastfeeding - You are already enrolled in another interventional clinical trial Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 40

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)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12617000231347