- ClinicalTrials.gov ID: NCT01190930
- Not accepting healthy volunteers
- UTSW Principal Investigator: Tamra Lynn Slone
summary
at the end of induction, after B-aLL patients have been stratified into risk subgroups, a second informed consent that describes the next portions of therapy must be signed prior to the start of Consolidation. There are separate post-induction consents for children with LR, DS and aR-aLL. The post-induction consent for patients stratified as aR-aLL will include the option of enrolling on the HRQoL ancillary studies assessing 1) patient burden (termed "The Patient Leukemia experience Study" in the consent) for all sites, and 2) the vincristine neuropathy study (termed "The Leukemia Physical Functioning Study" in the consent) at selected limited institutions. B-LLy and DS B-LLy patients will sign one consent form that describes all therapy to be received on study, prior to beginning induction therapy. aR-aLL patients will be approached with a third consent prior to beginning Maint therapy that describes the randomization to 1 of 4 different Maint arms. induction Therapy all patients will receive a common 3-drug dexamethasone-based induction with the exception of intravenous rather than intramuscular administration of pegaspargase. Post induction Therapy (Pre-Maintenance): average Risk (aR)- The aR subset of SR-aLL patients must consent prior to starting Consolidation therapy to receive 7 months of therapy identical to the iS-arm of CCG 1991: Consolidation, 2 interim Maintenance phases with vincristine and escalating iV methotrexate, and 1 Delayed intensification phase. Low Risk (LR)- Prior to starting Consolidation therapy to be randomized to receive either (a) Consolidation therapy identical to that on Regimen a of CoG P9904 with the exception that oral 6-MP in Consolidation will start 1 week later to allow time for the end-induction risk assignment (arm LR-M); or (b) therapy identical to that for aR patients with reduced vincristine/dexamethasone pulses at 12-week intervals during Maintenance (arm LR-C). The DS SR-aLL group will receive modified induction and post-induction therapy due to the higher risk of treatment-related morbidity and mortality and will not be included in the randomized questions. at the end of induction therapy, children with DS SR-aLL must consent prior to starting Consolidation therapy to receive therapy identical to the iS-arm of CCG 1991 with the following modifications: (1) leucovorin rescue will be given following intrathecal methotrexate in all phases prior to Maintenance; (2) Maintenance vincristine/dexamethasone pulses will be given every 12 weeks; (3) Maintenance duration will be 2 years from the start of iM i for both boys and girls. Post induction Therapy (Maintenance) average Risk (aR)- The aR subset of SR-aLL patients will be randomized to 1 of 4 Maintenance treatment arms at the end of iM ii: i.) arm a- vincristine/dexamethasone pulses at 4-week intervals, intrathecal methotrexate every 12 weeks and oral methotrexate at dose 20 mg/m2/week. ii.) arm B- vincristine/dexamethasone pulses at 4-week intervals, intrathecal methotrexate every 12 weeks and oral methotrexate at dose 40 mg/m2/week. iii.) arm C-vincristine/dexamethasone pulses at 12-week intervals, intrathecal methotrexate every 12 weeks and oral methotrexate at dose 20 mg/m2/week. iv.) arm D-vincristine/dexamethasone pulses at 12-week intervals, intrathecal methotrexate every 12 weeks and oral methotrexate at dose 40 mg/m2/week. Low Risk The LR subset of SR-aLL patients will have been randomly assigned to either: i.) arm LR-M - vincristine/dexamethasone pulses at 16-week intervals, intrathecal methotrexate every 12 weeks (until completion of 8 doses) and oral methotrexate at dose 20 mg/m2/week. Maintenance therapy starts at the end of Consolidation. ii.) arm LR-C - vincristine/dexamethasone pulses at 12-week intervals, intrathecal methotrexate every 12 weeks and oral methotrexate at dose 20 mg/m2/week. DS SR-aLL patients will be non-randomly assigned the arm DS Maintenance arms.
eligibility
- Patients must be enrolled on AALL08B1 (STU 092010-005; AALL08B1, Classification of Newly Diagnosed Acute Lymphoblastic Leukemia) prior to enrollment on AALL0932. (note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932.) - Patients must be > 365 days and < 10 years of age (for B-ALL patients) - Patients must be >365 days and <= 30.99 years of age (for B-LLy patients) - B-ALL patients must have an initial white blood cell count < 50 000/[MICRO-SYMBOL]L. - Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stages I or II (See Appendix V for staging). - Patients with Down syndrome are also eligible.