Study of Gelonin Purging of Autologous Stem Cells for Transplantation
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, MDS, Gelonin, Purging, Transplant, Peripheral Stem Cell
Eligibility Criteria
Inclusion Criteria: Patients with AML, RAEB-t, RAEB, or CMML who are in first remission and have poor prognosis cytogenetic abnormalities (i.e: deletions of chromosome 5, 7, 20; trisomy 8, t9,22,11q23 abnormalities or complex karyotypes).* Patients with AML, RAEB-t, RAEB, or CMML who are in second or subsequent remission. Remission is defined as ANC>1.5 x 109/Lt; Platelet count >100 x 109/Lt, and red cell transfusion independence. Male or female who have provided written informed consent. Tumor cells must be > 80 % CD-33 positive by flow cytometry. For women of childbearing potential (i.e., exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom) No chemotherapy for the two weeks prior to entering the study. No evidence of residual toxic effects from prior chemotherapy. Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38C. Must have at least 5 x 106 CD34+ peripheral blood stem cells collected. All patients who have had less than 7 x 106 CD34+ cells/kg collected, should have a bone marrow harvest to serve as back-up. A minimum of 1 x 106 CD34+ cells/kg of unpurged bone marrow or 2 x 106 CD34+ cells/kg of unpurged peripheral blood need to be stored as backup to be eligible for this protocol. Patients must have bilirubin less than 2.0, transaminases less than 4 x upper limit of normal. Pulmonary function tests >50% predicted for DLCO, FVC and FEV1 No active uncontrolled infection No active CNS disease No uncontrolled arrythmias Zubrod Performance Status less than or equal to 2 Exclusion Criteria: Active CNS disease
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan