Acute Lymphoblastic Leukemia
Conditions
Keywords
Rituximab, HyperCVAD
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.
Detailed description
Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients. In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission. Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.
Interventions
DRUGMethotrexate
Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.
DRUGCyclophosphamide
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
DRUGDoxorubicin
50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
DRUGVincristine
Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
DRUGDexamethasone
40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
DRUGCytarabine
2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
DRUGRituximab
Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month.
DRUG6-Mercaptopurine
Maintenance:60mg/m2 daily for 24 months.
DRUGPrednisone
Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
DRUGL-asparaginase
Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
Sponsors
Ruijin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CD20-positive ALL * Adequate liver function (bilirubin less than or equal to 1.5\*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5\*ULN, unless considered due to tumor) * Signed informed consent
Exclusion criteria
* Prior history of treatment with high-dose Ara-C, MTX or rituximab * Pregnant or lactating women * History of allergy to rituximab * Unable to sign informed consent * Active replication of HBV * History of stem cell transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR duration | After two 21-day courses | Bone marrow MRD examination every two months |
| disease free survival | 2 year | — |
Countries
China
Outcome results
None listed