Leukaemia,Lymphoblastic
Conditions
Brief summary
This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia.
Detailed description
All patients received a modified BFM regimen which was derived from the MRCUKALLⅫ/ECOGE2993 Regimen.The differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) Pegaspargase was used instead of L- asparaginase for patient.(3)Two additional Pegaspargase treatments were added into consolidation therapy.
Interventions
DRUGVincristine
induction therapy I：1.4 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 1)：1.4 mg/m2 IV d1, 8, 15, 22； Maintenance therapy: 1.4 mg/m2 intravenously every 3 months for a total of 2.5 years
DRUGDaunorubicin
induction therapy I：60 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 3)：25 mg/m2 IV d1, 8, 15, 22；
DRUGPegaspargase
induction therapy I: 2500U/m2,im,d8,22 Intensification therapy:2500U/m2 im, d2,23 consolidation therapy(Cycle 2，4)：2500U/m2 im, d1
DRUGPrednisone
induction therapy I：60 mg/m2 PO d1-28; Maintenance therapy:prednisone 60 mg/m2 orally for 5 days every 3 months for a total of 2.5 years
induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22
DRUGCyclophosphamide
induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29
DRUGCytarabine
induction therapy II:75 mg/m2 IV d1-4, 8-11, 15-18, 22-25 consolidation therapy(Cycle 1，2，4)：75 mg/m2 intravenously on days 1 to 5 consolidation therapy(Cycle 3):75 mg/m2 intravenously on days 31 to 34 and 38 to 41
DRUG6-Mercaptopurine
induction therapy II:60 mg/m2 PO d1-28 Maintenance therapy:75 mg/m2 orally each day for a total of 2.5 years
DRUGMethotrexate
Intensification therapy:3 g/m2 intravenously given on days 1, 8, and 22 Maintenance therapy:20 mg/m2 orally or intravenously once a week for a total of 2.5 years.
DRUGEtoposide
consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5
DRUGdexamethasone
consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28
DRUGthioguanine
consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42
50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* newly diagnosed ALL * age:18-35years * WBC count below 30×109/L(B lineage)；WBC count below 100×109/L(T lineage) * absence of t(9;22), t(1;19), t(4;11) or any other 11q23 rearrangements * receive no chemotherapy or radiotherapy before * Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
Exclusion criteria
* mismatch the inclusion criteria * systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | up to end of follow-up-phase (approximately 3 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to end of follow-up-phase (approximately 3 years) | — |
| complete remission rate | every 4 weeks,up to completion of induction treatment(approximately 2months) | — |
| Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | up to end of follow-up-phase (approximately 3 years) | including hematological safety and non-hematological safety. |
| Minimal Residual Disease (MRD) monitoring | During treatment at time point 4, 8, 12, 16,20,24, 28 weeks（every 4 weeks,up to completion of consolidation therapy）and 40，52，64，76，88，100，112，124 weeks( every 12 weeks during maintenance therapy,up to the end of treatment ) | Minimal residual disease is measured in bone marrow using an multiparameter flow cytometry.For the patients who achieved complete remission after induction therapy, if two consecutive tests for MRD were positive,we will define it as MRD positive |
Countries
China
Contacts
Primary Contacthua wang, MD.
Outcome results
None listed