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.