Inclusion Criteria

Inclusion Criteria for Collection Arm of the protocol:

Age < 26 years, whose disease meets one of the following 2 criteria:

- VHR patients in 1st CR

- NCI HR-ALL and age ≥ 13 years at diagnosis

- CNS-3 leukemia at diagnosis

- Day 29/End of Induction BM MRD > 0.01%

- Induction failure (M3 BM at Day 29/End of Induction)

- Hypodiploidy (n< 44 chromosomes and/or a DNA index < 0.81)

- t(9;22) ALL (Philadelphia Chromosome/Ph+ ALL)

- t(17;19) ALL

- MLL gene rearrangement

- Intrachromosomal amplification of chromosome 21 (iAMP21)

- Patients in 1st or subsequent marrow relapse (isolated or combined), at the time of
relapse, during retrieval therapy, or after achievement of CR.

Inclusion Criteria for Treatment Arm of this protocol:

- Age <26 years old

- Patients must have a history of relapsed/refractory CD19+ B-ALL involving the marrow
to be eligible for infusion of modified T cells. Please note ≥25% blasts by
morphology and/or flow cytometry constitutes a bone marrow relapse on this protocol.
Patients must also fulfill one of the following criteria to be eligible for infusion
of modified T cells:

- Second or greater (≥2) relapse

- Early first marrow relapse (1st CR <18 months)

- Intermediate/Late first marrow relapse (1st CR >18 months from 1st CR) with poor
initial response (≥5% blasts by morphology and/or flow cytometry) following
reinduction chemotherapy

- Refractory B-ALL

- Ineligible for HSCT as determined by the treating physician in consultation with
the BMT service

- Ineligible for continued cytotoxic chemotherapy as determined by the treating
physician

- Patients must not receive alternative therapy (e.g. chemotherapy) for up to 8-12
weeks following infusion of modified T cells unless progression of disease is
demonstrated

- KPS or Lansky score ≥ 60

- Pulmonary function (measured prior to conditioning chemotherapy):

o > 90% oxygen saturation on room air by pulse oximetry.

- Renal Function (measured prior to conditioning chemotherapy):

o Serum creatinine ≤2.0mg/dL for patients over 18 years or ≤2.5 x institutional ULN
for age

- Hepatic Function (measured prior to conditioning chemotherapy):

- AST ≤ 5 x the institutional ULN. Elevation secondary to leukemic involvement is
not an exclusion criterion. Leukemic involvement will be determined by the
presence of progressive relapse defined by escalating bone marrow or peripheral
blood leukemia blasts within the previous month and the absence of initiation of
know hepatotoxic medication (e.g. azoles).

- Direct bilirubin ≤ 2.5 x the institutional ULN

Exclusion Criteria:

- Karnofsky/Lansky performance status <60.

- Patients previously treated with allogeneic HSCT

- Patients with history of HIV, hepatitis B or hepatitis C infection

- Patients with any concurrent active malignancies as defined by malignancies
requiring any therapy other than expectant observation

- Patients will be excluded if they have isolated extra-medullary relapse of ALL