Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine

This study will follow the standard-of-care bone marrow transplant (BMT), with the only
exception being to gradually substitute post-transplant cyclophosphamide (on day +4 after
BMT) with bendamustine. Three dose levels are planned for the phase I component of the study,
consisting of a combination of sequentially reduced doses of cyclophosphamide and increased
doses of bendamustine (on day +4 after BMT) with the full dose cyclophosphamide on day +3
after BMT remaining unchanged.

Control patients will be patients that have declined to participate in the main trial but
will receive haploidentical BMT with the current standard of two days of PT-CY (and no
PT-BEN) and will be consented for the immune monitoring studies only.

Inclusion Criteria:

- Be willing and able to provide written consent/assent for the trial.

- Diagnosed with one of the following high-risk malignancies, which require
hematopoietic cell transplantation (HCT) but do not have an available Human Leukocyte
Antigen (HLA)-matched related or unrelated donor or acceptable cord blood

- High risk acute lymphoblastic leukemia (ALL) in 1st complete remission (CR1) or
greater

- High risk acute myelogenous leukemia (AML) in CR1 or greater

- High risk undifferentiated acute leukemia

- High risk myelodysplastic syndrome (MDS)

- Chronic Myelogenous Leukemia (CML) failing or intolerant to Tyrosine Kinase Inhibitors
(TKIs) or in accelerated, blastic phase, or in second or subsequent chronic phase

- Juvenile Myelomonocytic Leukemia (JMML)

- Lymphoma, (Hodgkin and Non-Hodgkins Lymphoma including marginal zone, follicular
lymphoma, chemotherapy-sensitive large-cell, mantle cell lymphoma, gray zone, and
Burkitt's lymphoma in remission).

- At least one haploidentical related donor is available for bone marrow harvest.

- Molecular based HLA typing for the HLA-A, -B, -Cw, beta chain (-DRB1) and - DQ Beta 1
Locus (DQB1loci) to the resolution is needed to establish haploidentity.

- A minimum match of 5/10 is required.

- No availability of an 8/8 HLA-matched related or unrelated donor or clinical urgency
for transplant (e.g., needed within 4-8 weeks) at which time an acceptable unrelated
donor will not be available.

Exclusion Criteria:

- Refractory acute leukemia (>5% blasts) or progressive disease

- Untreated or progressive central nervous system leukemia

- Refractory to chemotherapy lymphoma

- Co-morbidities precluding patient's ability to tolerate BMT

- Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) > 5 x upper limit of
normal (ULN)

- Bilirubin > 2 x ULN

- Creatinine greater than >2 x ULN for age or creatinine clearance/glomerular filtration
rate (GFR) <40 ml/min/1.73m2

- Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% of
normal or O2 Sat <92%

- Cardiac: left ventricular ejection fraction <35%

- Active infection at time of hospital admission of Haplo BMT

- Documented fungal infection within 3 months of BMT

- HIV positive

- Karnofsky score (adults) < 60% or Lansky score < 50% (pediatrics).

- Positive pregnancy test for women of childbearing age.

- Severe psychiatric illness or mental deficiency making compliance to treatment
unlikely and/or informed consent impossible.

- Any reason, at the investigator's discretion, that the participation of the patient in
this protocol would not be in patient's best interest, or where the patient would be
unable to adhere to the study requirements.