Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

Inclusion Criteria:

Patient Participants:

- Age: Must be older than 18 years, no upper age limit.

- Karnofsky performance status: Full intensity conditioning, 80-100%; reduced intensity
conditioning, 60-100%.

- Vital organ function: a) Cardiac: Left ventricular ejection fraction must be > 45%
assessed by multigated acquisition (MUGA) scan or echocardiogram. No myocardial
infarction within 6 months of transplant evaluation. b) Pulmonary: forced expiratory
volume at one second (FEV1), forced vital capacity (FVC), and adjusted diffusing
capacity of the lungs for carbon monoxide (DLCO) must be ≥ 50% of predicted values. c)
Liver: Transaminases (AST, ALT) less than 2 times upper limit of normal values. d)
Kidney: Estimated creatinine clearance ≥ 50 cc/min.

- Signed informed consent.

- Included disease conditions and remission status: a) Acute leukemia in First Complete
Remission (CR1) or second/subsequent CR. b) Chronic myeloid leukemia, primary
myelofibrosis, chronic myelomonocytic leukemia. c) Int-2 or high risk myelodysplastic
syndrome (MDS). d) Hodgkin lymphoma beyond CR1 with chemosensitive disease, Stable
Disease (SD) may be included if no mass >3 cm. e) Non-Hodgkin lymphoma in high risk
CR1 or subsequent CR (by clinical, cytogenetic or molecular criteria), primary
induction failure (PIF) or relapsed with chemosensitive disease. SD may be included if
no mass >3 cm. f) Multiple myeloma in CR/Very Good Partial Response (VGPR).

Donor Participants:

- Per Moffitt Cancer Center (MCC) Blood and Marrow Transplant (BMT) program practices,
an allele level matched (8/8 HLA A, B, C and DR) sibling or unrelated donor is
preferred. If a matched donor is not found, mismatched unrelated or haploidentical
donors may be considered.

- If a haploidentical donor is considered, parents, children, full siblings and in
selected cases, extended family, will have high resolution typing at the MCC HLA
laboratory. A familiar haploidentical donor is chosen among those who share at least
one HLA-A, B, C, DRB1 and DQB1 haplotype with the patient.

- Patient will be screened for antibodies targeting mismatched HLA antigens in potential
haploidentical donors (donor specific antibodies, DSA). Antibody screen and
confirmatory testing using Luminex single antigen-bead test will be done.

- Among several potential donors, will choose in order of priority: a) Matched
cytomegalovirus (CMV) immunoglobulin G (IgG) serologic status between donor and
recipient. b) ABO blood group system-matched donor preferred, then minor ABO mismatch,
then major ABO mismatch. c) Younger donor preferred: child, then sibling, and then
parent. d) For male recipient, male donor will be preferred. Avoid mother as a donor
unless no other choices.

Exclusion Criteria:

Patient Participants:

- Uncontrolled active bacterial, viral, fungal infection.

- Prior allogeneic HCT.

- Unwilling to comply with study requirements.

- Active, progressive or advanced disease based on diagnosis.