R3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)
The analysis of survival rates in R3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL) to improve treatment results for children with relapsed or resistant leukaemia by using chemotherapy and radiotherapy based on Minimal Residual Disease monitoring
University Hospitals of Leicester National Health Service (NHS) Trust
300 participants
Nov 17, 2006
Interventional
Conditions
Summary
Phase 3 This international trial investigates the use of multi-agent chemotherapy and radiotherapy in children with relapsed or resistant lymphoblastic leukaemia, based on early response as measured by minimal residual disease (MRD) levels, in order to improve treatment. Who is it for? You can join this study if you are aged 1–18 years and have been diagnosed with acute lymphoblastic leukaemia which has relapsed or does not respond to first-line treatment. Trial details Participants are treated with multi-agent chemotherapy and radiotherapy based on early response as measured by minimal residual disease (MRD) levels. (These are the low levels of cancer cells that remain in the body after treatment.) Regular sensitive testing is carried out on the bone marrow to measure how quickly the leukaemia is responding to treatment, and this information is used to help determine whether a transplant or more chemotherapy is a better option for each patient. For those children who show a particularly slow response to chemotherapy, extra intensive chemotherapy is used before transplant to try to improve the control of the leukaemia and improve the chance of cure. Any disease progression is monitored.
Eligibility
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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
multi-agent chemotherapy, based on early response as measured by minimal residual disease (MRD) levels Phase I Induction (weeks 1-4): Intrathecal Methotrexate, <2yrs 8mg; 2yrs 10mg; >3 yrs 12mg, on day 1,of week 1 and day 1 of Week 2. Idarubicin or Mitoxantrone, 10mg/m2 intravenous (IV) over 1 hour, on days 1 and 2 of week 1. Dexamethasone, 20mg/m2 orally in 2 divided doses per day (max 40mg/day), on days 1-5 of week 1 and days 1-5 of week 3. Vincristine, 1.5mg/m2 iv bolus (max 2mg as a single dose), on day 3, week 1, day 3 of week 2, day 3 of week 3, day 3 of week 4. Peg Asparaginase, 1000u/m2 intramuscular(im), on day 3 of week 1 and day 3 of week 3 OR Erwinase, 20,000units/m2 (im) on day 3 of week 1 and then alternate days for 12 doses in total. Phase II Consolidation (weeks 5-8): Dexamethasone, 6mg/m2 orally in 2 divided doses, on days 1-5 of week 5. Vincristine, 1.5mg/m2 (iv), Max 2mg as a single dose, on day 3 of week 5. Intrathecal Methotrexate, <2yrs 8mg; 2 yrs 10mg; >3 yrs 12mg, on day 1 of week 6 Methotrexate, 1000mg/m2 (iv) over 36 hours, on day 1 of week 6 Peg Asparaginase, 1000u/m2, (im) on day 2 of week 6, 4 hours after the end of methotrexate infusion. OR if allergic to E. Coli Asparaginase Erwinase, 20,000u/m2 (im), on day 2 of week 6, 4 hours after end of MTX infusion and then alternate days for 6 doses in total Cyclophosphamide, 440mg/m2 (iv) infusion over 30 minutes, on day 1-5 of week 7 Etoposide, 100mg/m2 (iv) over 4 hours, on days 1-5 of week 7. Phase III Intensification (weeks 9-13) Dexamethasone, 6mg/m2 orally in 2 divided doses, on days 1-5 of week 9. Vincristine, 1.5mg/m2 (iv), Max 2mg as a single dose, on day 3 of Week 9 Intrathecal Methotrexate, <2yrs 8mg; 2yrs 10mg; >3yrs 12mg, on day 1 of week 9. Cytarabine, 3000mg/m2 (iv) over 3 hours, every 12 hours, on day 1 and 2 of week 9 and day 1, 2 of week 10. Erwinase, 20,000u/m2 (im), on day 2 and day 4 of week 9 and on day 2 and day 4 of week 10. Prednisolone eye drops every 2 hours from day 1, week 9 and stopped 5 days after the last Cytarabine infusion. Intrathecal Methotrexate, <2yrs 8mg; 2yrs 10mg; >3yrs 12mg, on day 1 of week 12. Methotrexate, 1000mg/m2 (iv) over 36 hours, on day 1 of week 12 Erwinase 20,000u/m2 (im), on day 2 of week 12, 4hrs after the end of the Methotrexate infusion.
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ACTRN12608000495325