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Complete title: Transplantation of Umbilical Cord Blood in Patients with Hematological Malignancies Using a Treosulfan Based Preparative Regimen
|Research Study Number||2275.00|
|Principal Investigator||Colleen Delaney, MD, MSc|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL): Must have < 20% morphologic marrow blasts in an evaluable marrow sample (> 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible
- Myelodysplastic syndrome (MDS): Any 2001 World Health Organization (WHO) classification subtype; refractory anemia with excess blasts (RAEB)-2 patients may proceed directly to transplant but may also be considered for induction chemotherapy before transplant; patients with >= 20% morphologic marrow blasts require induction therapy to reduce morphologic marrow blasts below 5% before transplant
- Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors
- Patients =< 50 must have performance status score: Karnofsky (for adults) >= 70; Lansky (for children) score >= 50
- Patients > 50 must have Karnofsky performance score >= 70 and comorbidity index < 5
- Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction >= 35% OR fractional shortening > 22%
- Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:
- ** Diffusion lung capacity for carbon monoxide (DLCO) corrected >= 70% mm Hg
- ** DLCO corrected between 60% - 69% mm Hg and pO2 >= 70 mm Hg
- ** DLCO corrected between 50% - 59% mm Hg and pO2 >= 80 mm Hg
- Adequate hepatic function; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
- Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine clearance > 40 ml/min (pediatrics); all adults with a creatinine > 1.2 or a history of renal dysfunction must have estimated creatinine clearance > 40 ml/min
- If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease to proceed
- Second hematopoietic cell transplant: must be >= 3 months after prior myeloablative transplant
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Pregnancy or breastfeeding
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
- Uncontrolled viral or bacterial infection at the time of study enrollment
- Active or recent (prior 6 month) invasive fungal infection without infectious diseases (ID) consult and approval
- Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning (day -6)
- AML in first complete response (CR1) with favorable prognostic cytogenetics (t8;21, t15;17, inv16) and low risk MDS (International Prognostic Scoring System [IPSS] score 0)
Other exclusion criteria may apply.
Leukemia, Acute Lymphoid (ALL); Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD); Umbilical Cord Blood Transplant (UCBT)
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