AALL0932, Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Study ID
STU 092010-007

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • Children's Medical Center-Dallas

Contact
McGinn Stephanie
214 456-8588
stephanie.mcginn@childrens.com

Principal Investigator
Tamra 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 [Quote]The Patient Leukemia experience Study[Quote] in the consent) for all sites, and 2) the vincristine neuropathy study (termed [Quote]The Leukemia Physical Functioning Study[Quote] 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.

Participant 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.