| Eligibility |
Inclusion Criteria:
- Patients must have one of the following hematologic malignancies: a. Acute myelogenous
leukemia (AML), induction failure, high-risk for relapse first remission (with
intermediate-risk or high-risk cytogenetics, flt3 mutation positive and/or evidence of
minimal residual disease by flow cytometry), secondary leukemia from prior
chemotherapy and/or arising from myelodysplastic syndrome (MDS), Langerhan's cell
histiocytosis, any disease beyond first remission. b. Myelodysplastic syndrome (MDS):
MDS International Prognostic Scoring System (IPSS) INT-1 will be enrolled only if the
subjects have failed previous leukemia treatments and are transfusion-dependent. MDS
may be primary or therapy related, including patients that will be considered for
transplant. Including the following categories: 1) Revised IPSS intermediate and high
risk groups, 2) MDS with transfusion dependency, 3) Failure to respond or progression
of disease on hypomethylating agents, 4) Refractory anemia with excess of blasts, 5)
Transformation to acute leukemia, 6) Chronic myelomonocytic leukemia, 7) Atypical
MDS/myeloproliferative syndromes, 8) Complex karyotype, abn(3g), -5/5g-, -7/7g-,
abn(12p), abn(17p). c. Acute lymphoblastic leukemia (ALL) patients with the following
will be considered: induction failure, primary refractory to treatment (do not achieve
complete remission after first course of therapy) or are beyond first remission
including second or greater remission or active disease. Patients in first remission
are eligible if they are considered high risk, defined as any of the following
detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex
karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or
evidence of minimal residual disease, or acute biphenotypic leukemia which excludes >
7 chromosomal abnormalities, or double hit non-Hodgkin's lymphoma. Non-Hodgkin's
lymphoma (NHL) in second or third complete remission or relapse (including relapse
post autologous hematopoietic stem cell transplant), or relapsed double hit lymphoma.
Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with
progressive disease with progression after standard of care therapy or have
failed/been intolerant to ibrutinib. Chronic myelogenous leukemia (CML) second chronic
phase or accelerated phase. Hodgkin's disease (HD): Induction failure after the first
complete remission, or relapse (including relapse post autologous hematopoietic stem
cell transplant), or those with active disease.
- The first 6 patients must be >= 18 and =< 65 years old. The subsequent patients may
include pediatric patients >= 12 and =< 65 years old. Eligibility for pediatric
patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC)
pediatrician.
- Performance score of at least 80% by Karnofsky or performance score (PS) < 3 (Eastern
Cooperative Oncology Group [ECOG]) (age >= 12 years)
- Left ventricular ejection fraction of > 40%.
- Pulmonary function test (PFT) demonstrating a diffusion capacity of least 50%
predicted.
- Creatinine =< 1.5 mg/dL for patients 12 years old and older and =< 1 for patients
younger than 12 years old.
- Serum glutamate pyruvate transaminase (SGPT) =< to 2.0 x normal.
- Bilirubin =< to 2.0 x normal.
- Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing
potential defined as not post-menopausal for 12 months or no previous surgical
sterilization and willing to use an effective contraceptive measure while on study.
- Patients must have two cord blood (CB) units available which are matched with the
patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each
cord must contain at least 1.5 x 10^7 total nucleated cells/Kg recipient body weight
(pre-thaw).
- Have identified a backup cells source in case of engraftment failure. The source can
be autologous, related or unrelated.
- Patient must not have a 10/10 HLA matched family member or unrelated donor.
- Patients will have a back-up graft from any of the following: an available fraction of
autologous marrow; or peripheral blood progenitor cells (PBPCs) harvested and
cryopreserved; or family member donor; or a third cord blood unit.
- Prior to initiating chemotherapy in this study, twenty-one or more days must have
elapsed since the patient's last radiation or chemotherapy administration (Hydrea,
Gleevec and other tyrosine kinase inhibitors [TKI] as well as intrathecal therapy are
accepted exceptions).
Exclusion Criteria:
- Patients with known history of human immunodeficiency virus/acquired immunodeficiency
syndrome (HIV/AIDS).
- Patients with positive hepatitis serology that is definitive of active disease.
- Active central nervous system (CNS) disease in patient with history of CNS malignancy.
- Patients with chronic active hepatitis or cirrhosis. If positive hepatitis serology,
the study chair may deem the patient eligible based on the results of liver biopsy.
- Patients with uncontrolled serious medical condition such as persistent septicemia
despite adequate antibiotic therapy, decompensated congestive heart failure despite
cardiac medications or pulmonary insufficiency requiring intubation (excluding primary
disease for which CB transplantation is proposed), or psychiatric condition that would
limit informed consent.
- Positive beta HCG in female of child-bearing potential defined as not post-menopausal
for 12 months or no previous surgical sterilization or breast-feeding.
- Pediatric patients with acute lymphoblastic leukemia (ALL) that is t (9,22) positive
in first remission are not eligible unless there is evidence of minimal residual
disease after initial induction and/or consolidation treatment or the pediatric
Philadelphia chromosome positive (Ph+) ALL is clinically refractory to available
therapies with evidence of persistence in the bone marrow or peripheral blood.
- Patients with options for treatment that are known to be curative are not eligible.
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