T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts (MOHEL)
Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring haploidenticalstem cell transplant, acute lymphoblastic leukemia, Non Hodgkins Lymphoma, Myelodysplastic Syndrome, Acute myeloid leukemia, Chronic myelogenous leukemia, Hemophagocytic lymphohistiocytosis (HLH), Familial hemophagocytic lymphohistiocytosis (FLH), Viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP)
Eligibility Criteria
INCLUSION CRITERIA: Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor Age less than or equal to 55 years of age Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases. Myelodysplastic syndrome Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease. CML Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy Donor cells should be collected and frozen before conditioning starts EXCLUSION CRITERIA: Patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%) Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2) Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted) Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl) Patients with severe personality disorder or mental illness Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation Patients with documented HIV positivity 'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.
Sites / Locations
- Houston Methodist Hospital
- Texas Children's Hosptial
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
CLINIMACS Device
ISOLEX Device
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device