Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases
Hematologic Malignancy
About this trial
This is an interventional treatment trial for Hematologic Malignancy focused on measuring Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia, Non-Hodgkin's lymphoma, Hodgkin's disease, Myelodysplastic syndrome, Myeloproliferative disorders, Multiple myeloma, Severe aplastic anemia
Eligibility Criteria
Inclusion Criteria: Patients with one of the following high risk diseases needing allogeneic hemopoietic stem cell transplantation: Acute myeloid leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse Acute lymphoblastic leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse Chronic myeloid leukemia, either a) Accelerated phase, or b) Blast crisis, or c) Chronic phase and not achieving major cytogenetic response despite standard therapy Chronic lymphocytic leukemia, either a) Primary refractory, or b) Beyond first complete remission(CR1), Non Hodgkin's lymphoma, either a) Primary refractory, or b) Beyond first complete remission(CR1) Hodgkin's disease, either a) Primary refractory, or b) Beyond first complete remission(CR1), Myelodysplastic syndrome with IPSS score > 0. (Appendix A) Myeloproliferative disorders (with the exclusion of chronic myeloid leukemia) a) Primary Myelofibrosis with Lile score of 1 or 2 (Appendix B) b) Polycythemia Vera or Essential Thrombocythemia transformed to AML or Myelofibrosis and PV "spent phase" Multiple Myeloma with stage II or III disease Severe aplastic anemia Conditions that increase Treatment Related Mortality (need one or more to be eligible): Greater or equal to 35 years of age; Ejection Fraction of less than 50%; DLCO less than 50% or FEV1/FVC < 80% of predicted value; Diabetes Mellitus; Renal insufficiency (serum creatinine abnormal); Hepatic dysfunction-transaminases, or alkaline phosphatase, or bilirubin twice the upper limit of normal; Prior recent history of systemic fungal infection; Multiple prior treatment regimens (equal to or more than 3); Significant Grade III or IV neurologic, cardiac, pulmonary, renal or hepatic toxicity from previous treatment; Prior Autologous or Allogeneic Stem Cell transplantation; Available Healthy Donor without any contraindications for donation. 5/6 or 6/6 related or unrelated donor (molecular typing for DRB1); Patient and/or responsible person able to understand and sign consent Exclusion Criteria: Pregnant and lactating women, or women unwilling to use contraception. HIV positive patient Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) Child's class C cirrhosis Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months) Patients with known allergy to rat serum products
Sites / Locations
- Texas Children's Hospital
- The Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
recipients of HLA matched sibling transplants
recipients of unrelated or mismatched family donor transplants