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

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

Contact
Adrian Avila
214-456-8588
adrian.avila@childrens.com

Principal Investigator
Naomi Winick

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 and amp;quot;The Patient Leukemia Experience Study and amp;quot; in the consent) for all sites, and 2) the vincristine neuropathy study (termed and amp;quot;The Leukemia Physical Functioning Study and amp;quot; 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 be

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/μL.
- 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.