Prevention of Acute Graft Versus Host Disease in Patients Undergoing Allogeneic ApoGraft Stem Cell Transplantation

Recipient/patient main inclusion criteria:

1. Adult male or female subjects, 18-70 years of age.

2. Subjects are eligible for allogeneic HLA-matched related HSCT for any hematologicalmalignancies for which transplantation is appropriate with corresponding relateddonor. One of the following hemato-oncology disorders diagnosis is required:

• Acute myelogenous leukemia (AML) and Acute lymphoblastic leukemia (ALL) in 1st orsubsequent complete remission (CR)

• Non-Hodgkin's disease (NHD) in CR by CT or PET/CT

• Hodgkin's disease (HD) in 1st or subsequent CR by CT or PET/CT

• Intermediate, High or Very High Risk Myelodysplastic syndrome (MDS) (IPSS-Rcriteria)

3. The donor and recipient must have full match at the HLA A, B, C, DR and DQ loci.

4. ECOG performance status score 0-1 at time of the screening visit.

5. Subjects must have adequate organ function as defined in the study protocol

6. Signed written informed consent to participate in the study.

7. If female of childbearing potential, agree to use an acceptable method of birthcontrol or be surgically sterile, and have a negative pregnancy test. Donor main inclusion criteria:

8. Adult male or female subjects, 18-65 years of age.

9. Donor criteria according to standard WMDA criteria for donor selection. 3 Must havefull match at the HLA A, B, C, DR and DQ loci with the recipient.

10. Signed written informed consent

Recipient/patient main exclusion criteria:

1. Use of non-myeloabletive conditioning.

2. Uncontrolled infections including sepsis, pneumonia with hypoxemia, persistentbacteremia, or meningitis within two weeks of the screening visit.

3. Current known acute or chronic infection with HBV or HCV.

4. Known human immunodeficiency virus (HIV) infection or AIDS.

5. Subjects with severe or symptomatic restrictive or obstructive lung disease orrespiratory failure requiring ventilator support.

6. Subjects with other concurrent severe and/or uncontrolled medical condition, whichcould compromise participation in the study (i.e. active infection, uncontrolleddiabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina,ventricular arrhythmias, active ischemic heart disease, myocardial infarction withinsix months and chronic liver or renal disease.

7. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder orany chronic condition susceptible, in the opinion of the investigator, of interferingwith the conduct of the study.

8. Organ allograft or previous history of allogeneic stem cell transplantation.

9. Pregnancy or lactation. Donor main exclusion criteria:

10. HIV, HBV or HCV positive subjects.

11. Pregnant or lactating women.

12. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements.