Table 1.

Treatment and risk stratification differences on AALL1231 vs AALL0434

	AALL1231	AALL0434
Induction corticosteroid	Dexamethasone	Prednisone
	6 mg/m2 per d × 28 d	60 mg/m2 per d × 28 d
Maintenance corticosteroid	Dexamethasone	Prednisone
	6 mg/m2 per d × 5 d each 28-d cycle	40 mg/m2 per d × 5 d each 28-d cycle
Asparginase	2 doses of pegaspargase during induction	1 dose of pegaspargase during induction
	3 doses of pegaspargase during DI	2 doses of pegaspargase during DI
Interim maintenance	C-MTX if SR	Randomized to C-MTX or HD-MTX except
	HD-MTX and C-MTX if IR	Induction failure or CNS-3 and then HD-MTX
	VHR intensification blocks and C-MTX if VHR
Cranial Radiation T-ALL	CNS-3: 18 Gy during maintenance	CNS-3: 18 Gy during DI
	VHR: 12 Gy during maintenance	IR/HR C-MTX arm: 12 Gy during consolidation
	No radiation for SR/IR CNS-1 or CNS-2	IR/HR HD-MTX arm: 12 Gy during DI
		No radiation for LR
Cranial Radiation T-LLy	CNS-3: 18 Gy during maintenance	CNS-3 not eligible
	No radiation for patients with CNS-1 or CNS-2 T-LLy	No radiation for patients with CNS-1 or CNS-2 T-LLy
Randomized questions		± nelarabine (6, 5-d courses): all patients but LR and induction failure. Induction failure nonrandomly assigned to received nelarabine
	± bortezomib during induction and delayed intensification all patients	C-MTX vs HD-MTX interim maintenance as described above
Risk stratification
LR		National Cancer Institute SR by age (1.00-9.99 y) and WBC (initial ≤50 000/μL); RER, M1 on d 15 and M1 marrow with MRD <0.1% on d 29; CNS-1 status and no testicular disease at diagnosis
SR	CNS-1, lumbar puncture before steroid therapy (not steroid pretreated), d 29 (end of induction) bone marrow M1, d 29 bone marrow MRD ≤0.01%, no testicular leukemia at diagnosis
	CNS-2 and CNS-3 cannot be SR and are assigned to IR or VHR based on marrow response
IR	Not SR or VHR	RER or SER, M1 marrow with MRD <1% on d 29; any CNS status
HR		M2 marrow and/or MRD ≥1% on d 29; any CNS status
VHR	M3 marrow at d 29 and/or end of consolidation MRD ≥0.1%

Other components of therapy, including type and doses of anthracyclines and alkylating agents were the same in both trials. Supplemental Table 2 provides a detailed description of AALL1231 therapy; the same doses and schedules were used in AALL0434 except those noted in Table 1.

RER: M1 marrow on either day 8 or 15, and M1 marrow with MRD <0.1% on day 29.

SER: M2 or M3 marrow on day 15 or positive MRD ≥0.1% on day 29. M1/M2 marrow on day 29.

LR, low risk; RER, rapid early responder; SER, slow early responder; SR, standard risk; T-LLy, T-cell lymphoblastic lymphoma.