Microtransplantation to Treat Refractory or Relapsed Hematologic Malignancies in Younger Patients

INCLUSION CRITERIA - AML and MDS PARTICIPANTS

Participants must have a diagnosis of AML or myelodysplastic syndrome (MDS), ALL, and must have disease that has relapsed or is refractory to chemotherapy, or that has relapsed after HSCT.

Refractory disease is defined as persistent disease after at least two courses of induction chemotherapy.
Patients with AML must have ≥ 5% leukemic blasts in the bone marrow or have converted from negative minimal residual disease (MRD) status to positive MRD status in the bone marrow as assessed by flow cytometry. If an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia in the peripheral blood.
Participant is ≤ 21 years of age (i.e., has not reached 22nd birthday).

Adequate organ function defined as the following:

Total bilirubin ≤ upper limit of normal (ULN) for age, or if total bilirubin is > ULN, direct bilirubin is ≤ 1.5 mg/dL
AST (SGOT)/ALT (SGPT) < 5 x ULN
Calculated creatinine clearance > 50 ml/min/1.73m^2 as calculated by the Schwartz formula for estimated glomerular filtration rate >
Left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25%.
Has an available HPC-A donor.
Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥ 50% for patients who are > 16 years old.
Does not have an uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable.

Patient has fully recovered from the acute effects of all prior therapy and must meet the following criteria.

At least 14 days must have elapsed since the completion of myelosuppressive therapy.
At least 24 hours must have elapsed since the completion of hydroxyurea, low-dose cytarabine (up to 200 mg/m^2/day), and intrathecal chemotherapy.
At least 30 days must have elapsed since the use of investigational agents.
For patients who have received prior HSCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HSCT. Patients cannot be receiving therapy, including steroids, for GVHD.
Post-menarchal female has had negative serum pregnancy test within 7 days prior to enrollment.
Male or female of reproductive potential has agreed to use effective contraception for the duration of study participation.
Not breastfeeding

INCLUSION CRITERIA - HPC-A CELL DONOR

At least 18 years of age.
Family member (first degree relatives).
Not pregnant as confirmed by negative serum or urine pregnancy test within 7 days prior to enrollment (if female).
Not breast feeding.
Meets donation eligibility requirements as outlined by 21 CFR 1271.