CompletedPhase 2ACTRN12611000814976

A Multicentre trial for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed Acute Lymphoblastic Leukaemia (ALL)

A phase II trial of an intensive pediatric protocol incorporating post-induction stratification based on minimal residual disease levels for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed ALL

Sponsor

Australasian Leukaemia and Lymphoma Group

Enrollment

100 participants

Start Date

Sep 21, 2012

Study Type

Interventional

Conditions

Untreated ALL aged 15 to 40 years

Summary

This study will be a national clinical trial that will evaluate the safety and efficacy of a chemotherapy treatment, administered to adolescents and young adults with a newly diagnosed bone marrow cancer, called acute lymphoblastic leukaemia (ALL). Who is it for? You may be able to join this study if you are aged between 15 to 40 years and have been recently diagnosed with acute lymphoblastic leukaemia (ALL), for which you have not yet undergone any treatment. Trial details: ALL is the most common form of childhood cancer, but in over 80% of children it can be cured with chemotherapy. Adults with ALL do much worse and this trial will examine whether exactly the same treatment given to children can also be given to adults, and if so, are the results as good. In order to determine this, all patients in this trial will be administered the same chemotherapy treatment given to children. Patients' response to this chemotherapy will determine subsequent treatment. Participants in this trial will be regularly assessed throughout this trial to determine remission rates, survival, toxicity and quality of life.

Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests a treatment regimen for adolescents aged 15 and older and young adults up to 40 with newly diagnosed acute lymphoblastic leukaemia (ALL). Participants must have at least 20% blasts in their bone marrow, adequate organ function, and cannot have the Philadelphia chromosome-positive subtype or mature B-cell/Burkitt ALL.

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

All patients will commence treatment with Protocol I which is an intensive chemotherapy induction protocol. Various prognostic factors such as cytogenetic abnormalities, initial response to prednisolone, achievement of remission, and MRD levels after induction and consolidation, will determine whether patients continue treatment outlined in Protocol M, or are to be treated on the High Risk protocol, or undergo allogeneic Haemopoietic Cell Transplantation (HCT). Patients removed for allogeneic HCT will be withdrawn from the study, but will continue to be followed, with relapse, disease-free and overall survival data being recorded. PROTOCOL I, Phase 1, Days 1-35: i) Intrathecal Methotrexate (IT MTX) on days 1, 15, 33. ii) Prednisolone (PRED) 60mg/m^2/day orally in 2 divided doses per day on Days 1-7. On Days 8-28 PRED 60mg/m^2/day in 3 divided doses. On Days 29-38: PRED taper in 3 stages every 3 days. Reduce dosage by half at each stage. iii) Vincristine (VCR) 1.5mh/m^2/day IV bolus (maximum single dose 2mg) Days 8, 16, 22 and 29. iv) Daunorubicin (DNR) 30mg/m^2 IV over 1 hr Days 8, 16, 22, 29. v) Pegylated Asparaginase (LINK) 1000U/m^2 IM or IV on Days 8 and 22. PROTOCOL I, Phase 2, Days 36-64: i) Cytarabine (ARA-C) 75mg/m^2/day IV or SC in 4 x 4 day blocks on Days 36, 37, 38, 39; Days 43, 44, 45, 46; Days 50, 51, 52, 53; Days 57, 58, 59, 60. ii) Cyclophosphamide (CPA) 1000mg/m^2/day/IV over 1 hour, Days 36 and 64. iii) 6-Mercaptopurine (MP) 60mg/m^2/day orally on Days 36-63, 28 days total. iv) Intrathecal Methotrexate (IT MTX) on Days 43 and 57 with the second and fourth cytarabine blocks. PROTOCOL M for Standard and Medium Risk only. Scheduled to commence on Day 79 after the start of Protocol 1, provided there is adequate count recovery. i) 6-Mercaptopurine (MP) 25 mg/m^2/day orally over 8 weeks, Days 1-56. ii) High Dose Methotrexate (HD-MTX) 5g/m^2 as a continuous infusion over 24 hours, on Days 8, 22, 36, 50. iii) Intrathecal Methotrexate (IT MTX) administered at 2 hours after the start of the MTX-infusion on Days 8, 22, 36, 50. HIGH RISK PROTOCOL, Block HR-1, normally begins directly after completion of Protocol I. i) Dexamethasone (DEXA) 20mg/m^2/d orally or by IV in 2 divided doses on Days 1-5. ii) Vincristine (VCR) 1.5mg/m^2/daily (maximum single dose 2mg) IV on Days 1 and 6. iii) High Dose Methotrexate (HD-MTX) 5g/m^2, infused IV over 24 hours on Day 1. iv) Cyclophosphamide (CPA) 200mg/m^2/twice daily IV over 1 hour, Days 2-4. v) Cytarabine (HD-ARA-C) 2g/m^2/twice daily, IV over 3 hours on Day 5. vi) Pegylated Asparaginase (ASP) 1000U/m^2 IM or IV on Day 6. vii) Intrathecal Methotrexate (MTX) 12 mg/Cytarabine (ARA-C) 30mg/Hydrocortisone 50mg on Day 1. HIGH RISK PROTOCOL, Block HR-2: The doses and scheduling of i) DEXA ii) HD-MTX/LCV-Rescue iii) ASP iv) MTX/ARA-C/HYDROCORTISONE IT are the same as in block HR-1. Additional therapy in HR2: v) Vindesine (VDS) 3mg/m^2/daily (maximum single dose 5mg) IV on Days 1 and 6. vi) Ifosfamide (IFO) 800mg/m^2/twice daily IV over 1 hour on Days 2-4. vii) Daunorubicin (DNR) 30mg/m^2/daily IV over 1 hour on Day 5. HIGH RISK PROTOCOL, Block HR-3: i) DEXA ii) ASP as in block HR-1. Additional therapy in HR-3: iii) Cytarabine (HD-ARA-C) 2g/m^2/twice daily IV over 3 hours, Days 1-2. iv) Etoposide (VP-16) 100mg/m^2/twice daily IV over 1 hour every 12 hours, Days 3-5. v) Intrathecal Methotrexate, Cytarabine, Hydrocortisone (MTX/ARA-C/HYDROCORTISONE IT) on Day 5. PROTOCOL II, Phase 1, Days 1-35: i) Dexamethasone (DEXA) 10mg/m^2/day orally in 2-3 divided doses, Days 1-21. From Day 22 on, reduce the dose every 3 days by half and stop on Day 29. ii) Vincristine (VCR) 1.5mg/m^2/day IV bolus (maximum single dose 2mg) on Days 8, 15, 22, 29. iii) Doxorubicin (DOX): 30mg/m^2/day IV over 1 hour on Days 8, 15, 22, 29. iv) Pegylated L’Asparaginase 1000U/m^2 IM or IV on Day1. v) Intrathecal Methotrexate (IT MTX) on Days 1, 18 ONLY IF CNS disease at diagnosis. PROTOCOL II, Phase 2, Days 36-50: i) Cytarabine (ARA-C) 75mg/m^2/day IV or SC in 2 x 4 day blocks. Days 36, 37, 38, 39 and Days 43, 44, 45, 46. ii) Cyclophosphamide (CPA) 1000mg/m^2 IV over 1 hour, Day 36. iii) 6-Thioguanine (6-TG) 60mg/m^2/day orally, Day 36-49, a total of 14 days. iv) Intrathecal Methotrexate (IT MTX) at the same time as the first dose of Cytarabine in Block 1 (Day 36) and Block 2 (Day 43). MAINTENANCE THERAPY begins 2 weeks after the end of Protocol II. Total therapy, calculated from the start of Protocol I, is 24 months for all patients. i) 6-Mercapoturine (MP) 50mg/m^2/day orally. ii) Methotrexate (MTX) 20mg/m^2/week, orally once a week at night.