Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation

Inclusion Criteria:

Age less than or equal to 21 years.

One of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic hematopoietic cell transplant (HCT):

ALL, AML, Myeloid Sarcoma, CML, Juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL)
Has a suitable single haplotype matched (≥ 3 of 6) family member donor.
Does not have any other active malignancy other than the one for which this transplant is indicated.
If prior central nervous system (CNS) leukemia, it must be treated and in CNS complete remission (CR)
Does not have current uncontrolled bacterial, fungal, or viral infection.
Patient must fulfill pre-transplant evaluation:
Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%.
Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2.
Forced vital capacity (FVC) ≥ 40% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing.
Karnofsky or Lansky (age-dependent) performance score ≥ 50 (See Appendix A).
Bilirubin ≤ 3 times the upper limit of normal for age.
Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age.
Not pregnant. If female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment.
Not breast feeding
DONOR: At least single haplotype matched (≥ 3 of 6) family member
DONOR: At least 18 years of age.
DONOR: HIV negative.
DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).
DONOR: Not breast feeding.

DONOR: Regarding donation eligibility, is identified as either:

Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.