Condition

• Hematologic Malignancies

Eligibility

Eligible Ages

Under 60 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

1. Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years
of age or older at the time of consent.

2. Patient must have relapsed >100 days since first transplant.

3. Diagnosis and Disease Status:

a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (<5%
blasts) at the time of transplant, with or without persistent cytogenetic, flow
cytometric, or molecular aberrations, or those with hypocellular marrows at time of
transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in
morphologic remission with less than 5% blasts at time of transplant, with or
without persistent cytogenetic, flow cytometric or molecular aberrations, or those
or who have hypocellular bone marrows, are eligible. c. Other acute leukemias: i.
Acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission
with less than 5% blasts at time of transplant, with or without persistent
cytogenetic, flow cytometric or molecular aberrations, or those who have
hypocellular bone marrows, are eligible. d. Myelodysplastic Syndromes (MDS) or CMML
without myelofibrosis. i. Includes MDS with any IPSS risk category.

4. Prior treatment:

a. To be eligible for this study, patients need to have received one prior
allogeneic stem cell transplantation.

5. Karnofsky score equal or greater than 70% for patients aged 16 years and older or
Lansky score equal or greater than 70% for patients less than 16 years old (See
Appendix B; inpatient Leukemia service transfers without discharge are acceptable
provided patient has equivalent KPS as if were outpatient).

6. Renal and Liver function:

1. Calculated creatinine clearance > 50 ml/min.

2. Bilirubin < 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).

3. ALT < 5 x upper limit of normal (ULN).

7. Pulmonary function: corrected diffusion capacity of the lung for carbon monoxide
(DLCO) > 60% predicted. This criteria is waived for patients who are developmentally
unable to complete pulmonary function test.

8. Left ventricular ejection fraction (MOD-bp) > 50%.

9. Graft Criteria:

1. Two CB units will be selected according to the current MDACC CB unit selection
algorithm.

2. High resolution 8-allele HLA typing and recipient HLA antibody profile will be
performed.

3. Unit selection will occur based on HLA-match, total nucleated cell (TNC), and
CD34+ cell dose adjusted per patient body weight.

4. The bank of origin will also be considered.

5. Donor-specific HLA antibodies, if present, will also be taken into
consideration.

6. Each CB unit must be at least 3/8 HLA-matched to the patient considering
high-resolution 8-allele HLA typing.

7. Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5
x 107 TNC/ recipient body weight (TNC/ kg).

8. Each CB unit will be required to have a cryopreserved CD34+ cell dose of at
least 1.0 x 105 CD34+ cells/ recipient body weight (CD34+ cells/kg).

9. A minimum of one unit will be reserved as a backup graft.

10. Each CB unit will be required to be cryopreserved in standard cryovolume. (24-
27 ml/s per unit) and be red blood cell depleted.

Recruiting Locations

Study Contact

Detailed Description

Primary Objective: To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation. Secondary Objectives: Speed and success of neutrophil and platelet engraftment. Incidences of graft failure. • Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD. Incidence of 1-year, 2-year, and 3-year cGVHD. Incidence of TRM (100 days, 6 months, 1 and 2 years). The probabilities of relapse, OS, PFS, and GRFS at 1 year, 2, and 3 years as listed in the secondary endpoints in section 2.2. Correlative laboratory studies investigating graft versus leukemia biology.