Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies
Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Allogeneic stem cell transplantation, Haploidentical stem cell transplant, Mismatched family member stem cell donor transplant, Bone marrow transplant, High risk hematological malignancies, T-cell depletion methodology, Miltenyi Biotec CliniMACS stem cell selection device
Eligibility Criteria
Inclusion Criteria: Eligible participants were assigned to one of two different strata dependent on diagnosis, disease status and/or past transplant experience. Both strata received the same intervention but will be followed and analyzed separately. Group A must have one of the following diagnosis Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in first remission Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow Chronic myeloid leukemia (CML) Juvenile myelomonocytic leukemia (JMML) Myelodysplastic syndrome (MDS) Paroxysmal nocturnal hemoglobinuria (PNH) Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission after autologous HSCT, or unable to have hematopoietic stem cells collected for autologous HSCT Group B must have one of the following refractory diagnosis (chemoresistant relapse or primary induction failure) Acute lymphoid leukemia (ALL) Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow Secondary AML / MDS Chronic myeloid leukemia (CML) in accelerated phase or blast crisis Juvenile myelomonocytic leukemia (JMML) Myelodysplastic syndrome (MDS) Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by autologous HSCT or who have chemo-resistant disease Or patients who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of the Transplant Faculty makes standard myeloablation prohibited At least 2 and less than or equal to 21 years of age Lacks suitable HLA-identical sibling or matched available unrelated donor and has a mismatched family member donor that is available, HIV negative and at least 18 years old Cardiac shortening fraction ≥ 25% Creatinine clearance ≥ 40 cc/min/1.73m^2 FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L Karnofsky or Lansky (age dependent) performance score of ≥ 50 Exclusion Criteria: Known allergy to murine products Lactating (female patient) Pregnancy (female patient) Active central nervous system (CNS) leukemia
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Other
1