Treatment of Adult B-ALL

· Used at UHN for our paper:

§ DFCI ALL Consortium Protocol 91-01

· Randomized to:

o Pulses of high-dose IV 6-MP during first year of post-remission therapy

o Pulses of standard-dose oral 6-MP during first year of post-remission therapy

· Dexamethasone substituted for prednisone during post-remission

· Duration of high-dose asparaginase intensification was extended from 20 weeks to 30 weeks.

· Full protocol:

o Investigational window (3 d)

§ Steroid 3 3 d (randomized): prednisone (40 mg/m2/d) or dexamethasone (6, 18, or 150 mg/m2/d)

§ IT cytarabine* (dosage by age 3 1 dose, d 0)

o Induction (4 wk)

§ Vincristine (1.5 mg/m2/wk; maximum, 2 mg)

§ Prednisone (40 mg/m2/d)

§ Doxorubicin (30 mg/m2 per dose; d 1 and 2)

§ Methotrexate (4 gm/m2, 8-24 h after doxorubicin) with

§ leucovorin rescue

§ IT cytarabine* (dosage by age 3 1 dose, d 17)

o CNS therapy (3 wk)

§ SR girls: IT methotrexate†/cytarabine* (3 4 doses for 2

§ wk, then q 18 wk)

§ SR boys and all HR patients: cranial XRT 1800 cGy

§ (randomized): hyperfractionated (90 cGy bid) or

§ conventional (180 cGy qd) with IT

§ methotrexate/cytarabine (dosage as in SR

§ patients)

o Intensification q 3-wk cycles (30 wk)

§ SR: vincristine (2.0 mg/m2 IV q 3 wk; maximum, 2 mg)

§ dexamethasone (6 mg/m2/d PO 3 5 d)

§ methotrexate (30 mg/m2 IV or IM q wk)

§ 6-MP (randomized):

§ high-dose: 1000 mg/m2 IV for 20 h, wk 1 and 2 or

§ conventional: 50 mg/m2/d PO 3 14 days

§ asparaginase (randomized):

§ PEG 2500 IU/m2 IM q 2 wk 3 15 doses or

§ E coli 25 000 IU/m2 IM q wk 3 30 doses

§ HR: same as SR patients, except:

§ dexamethasone dose (18 mg/m2/d PO 3 5 d)

§ no methotrexate

§ doxorubicin (30 mg/m2 q 3 wk; cumulative dose, 360

§ mg/m2) (randomized):

§ continuous infusion for 48 h or IV bolus

o Continuation q 3-wk cycles (until 2 y CCR)

§ SR: same as intensification, except no asparaginase; all 6-MP given via conventional dose (50 mg/m2/d x 14 d)

§ HR: same as SR patients, except dexamethasone dose

§ (as above)

References:

· Silverman L et al. Blood. 2001;97:1211-1218

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