Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency ...
Participants will be screened with a medical history, physical examination, blood and urine tests, and bone marrow samples to ... Participants will receive a transfer of their corrected blood stem cells about 36 to 48 hours after the second dose of busulfan ... followed by busulfan for 2 days. Palifermin will help prevent side effects from busulfan, and busulfan will help suppress the ... The primary treatment for XSCID is replacement of the patient s immune system with a normal immune system through a bone marrow ...https://clinicaltrials.gov/show/NCT01306019
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies - Full Text View -...
Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 ... Blood And Marrow Transplantation Leukemia Lymphoma Transplantation Infection Transplantation, Bone Marrow Drug: Melphalan Drug ... Number of Participants with engraftment within 42 days [ Time Frame: 42 days ]. Engraftment is defined as the evidence of donor ... Drug: Busulfan Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9 ...https://clinicaltrials.gov/ct2/show/NCT01471067?recr=Open&cond=%22Blood%22&rank=17
Busulfan and Fludarabine in Patients With AML and MDS - Full Text View - ClinicalTrials.gov
... in combination with Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern cell transplantation ... 1 will initially receive a therapeutic test dose of busulfan to test the blood levels over time; this information will be used ... Number of Participants With Successful Engraftment [ Time Frame: Study period one week prior to transplant through post Day 28 ... Bone Marrow Diseases. Hematologic Diseases. Fludarabine. Fludarabine phosphate. Busulfan. Vidarabine. Antineoplastic Agents. ...https://clinicaltrials.gov/ct2/show/NCT00502905
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation - Full Text View - ClinicalTrials.gov
... matched bone marrow and peripheral blood transplant. Subjects receive combination of single daily dose thiotepa (5 mg/kg) added ... Subjects receive combination of single daily dose thiotepa (5 mg/kg) added to the backbone of targeted reduced dose IV busulfan ... the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV ... Individual Participant Data (IPD) Sharing Statement:. Plan to Share IPD:. No. Plan Description:. There is no plan at this time. ...https://clinicaltrials.gov/ct2/show/study/NCT03513328
Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance
5. Study participants in whom the minimum stem cell dose of 2.0 x 106 cluster of. differentiation (CD)34+ cells/kg has been ... 3. Untreated bone marrow sample was shipped to Princess Margaret Hospital for MRD assay.. 4. Must have been treated with a ... 7. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test in all women of. child-bearing potential (WOCBP).. 8. ... day of busulfan dose. If cyclophosphamide was used for stem cell harvest, an ECHO or. MUGA must be done after the stem cell ...http://www.knowcancer.com/cancer-trials/NCT01702831/
A Pilot Trial Examining Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic Stem Cell...
... blood and bone marrow following transplantation (Objective #2). The site will correlate these laboratory results with clinical ... Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works ... A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III ... The site will use a myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define clinical endpoints ...https://cancer.dartmouth.edu/patients/clinical_trial/D16127/
Donor Stem Cell Transplantation for Congenital Immunodeficiencies - Full Text View - ClinicalTrials.gov
... doses of a drug called busulfan and lower doses of radiation than what are currently being used in other kinds of bone marrow ... During these visits the patient will have a physical examination and blood tests. The doctor and nurse will also check any ... treatments are given to patients to create space in their bone marrow. This lets the cells of the donor go into the bone marrow ... To create space in the bone marrow, patients are given two drugs, Campath-1H and busulfan. To prevent the body from getting rid ...https://clinicaltrials.gov/ct2/show/NCT00426517?term=NIAID&recr=Recruiting&no_unk=Y&cond=allergy+OR+asthma+OR+diabetes+OR+transplant+OR+multiple+sclerosis+OR+psoriatic+arthritis+OR+lupus&rank=1
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous...
Drug: Busulfan Test dose (32 mg/m^2) on day -9 then 130 mg/m^2 by vein or adjusted dose on Days -7, -6, -5, and -4. ... plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria. ... Progression-Free Survival (PFS) Rates of Busulfan + Melphalan (Bu-Mel) with Melphalan Alone in Participants with Multiple ... Experimental: Busulfan + Melphalan Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, ...https://clinicaltrials.gov/ct2/show/NCT01413178
Study of Gelonin Purging of Autologous Stem Cells for Transplantation
harvest or from a bone marrow harvest.. Part III:. HIGH DOSE FLUDARABINE/BUSULFAN WITH AUTOLOGOUS STEM CELL TRANSPLANT:. All ... Three days after participants. receive the last dose of busulfan, they will receive their previously stored stem cells. through ... Pulmonary function tests >50% predicted for DLCO, FVC and FEV1. - No active uncontrolled infection. - No active CNS disease. - ... 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/ ...http://www.knowcancer.com/cancer-trials/NCT00043810/
GVAX vs. Placebo for MDS/AML After Allo HSCT - Full Text View - ClinicalTrials.gov
... bone marrow aspirate and biopsy, blood tests, tuberculosis skin test, HLA antibody test, pregnancy test, urine test, ECHO, MUGA ... your transplant doctor will decide whether you receive a higher or lower dose of busulfan. Between 1-2 days after you finish ... Triple (Participant, Care Provider, Investigator). Primary Purpose:. Treatment. Official Title:. A Randomized Placebo- ... a blood draw for future immune tests and a bone marrow biopsy and aspirate to assess your MDS/CMML/AML. ...https://clinicaltrials.gov/ct2/show/study/NCT01773395?show_desc=Y
Immunoablative Mini Transplant (Hematopoietic Peripheral Blood Stem Cell Transplant [HPBSC]) - Full Text View - ClinicalTrials...
Bone Marrow Diseases. Hematologic Diseases. Busulfan. Alkylating Agents. Molecular Mechanisms of Pharmacological Action. ... The standard treatment in many disorders of the bone marrow is high dose chemotherapy and whole-body radiation treatment ... by pulmonary function test. For children who are uncooperative for pulmonary function tests and have no evidence of dyspnea at ... Procedure: Busulfan pharmacokinetics Pharmacokinetics of once-a-day dosing of intravenous busulfan as a 3-hour infusion ...https://clinicaltrials.gov/ct2/show/NCT00179764?term=leukemia+%5BCONDITION%5D+AND+child+%5BAGE-GROUP%5D&recr=Open&rank=17
Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With...
... of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg, unless approved otherwise by Dr. Holmberg); prior to stem cell collection ... Pre-Study tests have been performed. *Patient must sign an institutional review board (IRB) approved informed consent, ... Individual Participant Data (IPD) Sharing Statement:. Plan to Share IPD:. No. Studies a U.S. FDA-regulated Drug Product:. Yes. ... Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With ...https://clinicaltrials.gov/ct2/show/NCT00003875
Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
... out of 6 possible doses) that can be given in combination ... clinical research study is to find the highest tolerable dose ... Up to 6 dose levels of gemcitabine will be tested. Up to 3 participants will be enrolled at. each dose level. The first group ... To collect a bone marrow aspirate, an area of the hip or other site is numbed. with anesthetic, and a small amount of bone ... Test doses are used to study how your body breaks down busulfan. and decide the dose of busulfan that you will receive. You may ...http://www.knowcancer.com/cancer-trials/NCT01701986/
Stem Cell Gene Therapy to Treat X-Linked Severe Combined Immunodeficiency (XSCID) - Full Text View - ClinicalTrials.gov
Patients must have less than or equal to 3% of their mobilized CD34+ cells deriving from their allogeneic bone marrow donor. ... XSCID patients who are enrolled in the study will receive a single dose of their own cells that have been modified by the GALV ... Subjects who are older than the age of 3 will be given a conditioning regimen consisting of Fludarabine and Busulfan then they ... be unfrozen and exposed for four days in a row to growth factors and particles of a retrovirus we have constructed and tested ...https://clinicaltrials.gov/ct2/show/NCT00028236
Gene Therapy for Metachromatic Leukodystrophy - Full Text View - ClinicalTrials.gov
Busulfan will be administered to the patients to enable engraftment of the transduced stem/progenitor cells in the bone marrow ... We have developed and tested a clinically applicable LV containing the ARSA cDNA controlled by a constitutive eukaryotic ... Dose: ≥ 2x10^6 transduced CD34+ cells/Kg (maximum 20x10^6) at bedside for infusion. ... 14 participants. Intervention Model:. Single Group Assignment. Masking:. None (Open Label). Primary Purpose:. Treatment. ...https://clinicaltrials.gov/ct2/show/NCT01560182?term=Metachromatic+Leukodystrophy&rank=4
A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing...
Relapsed and refractory AML with ,5% blasts in bone marrow or extramedullary disease (excluding active disease of the central ... All patients will receive the same dose of busulfan. The dose of clofarabine will be escalated in successive cohorts of ... Women of childbearing potential should have a negative pregnancy test prior to study entry. Women and men of reproductive ... 18 participants. Intervention Model:. Single Group Assignment. Masking:. None (Open Label). Primary Purpose:. Treatment. ...https://clinicaltrials.gov/ct2/show/NCT00477542
Allogeneic transplantation as post-remission therapy for cytogenetically high-risk acute myeloid leukemia: landmark analysis...
1980) Bone-marrow ablation and allogeneic marrow transplantation in acute leukemia. N Engl J Med 302(19):1041-6. ... After July 2001 all patients and donors were tested at least for HLA-A, and -B by at least intermediate-resolution DNA typing ... 2009) Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: a study by the German Acute Myeloid ... Written informed consent was provided by all participants. The study was registered at Clinicaltrials.gov as NCT00266136. ...http://www.haematologica.org/content/96/7/972
TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome
Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis. Bone Marrow ... Out of 64 individuals, 61 participants had sustained engraftment, whereas 3 participants rejected their grafts. Three ... All individuals with morphologic CR who were tested by polymerase chain reaction (n=11) achieved negative molecular results, ... busulfan, and interferon alfa. ... When the bone marrow infused during a bone marrow transplant ...https://www.unicare.com/medicalpolicies/policies/mp_pw_a045973.htm
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS - Full Text View - ClinicalTrials...
Unrelated bone marrow or peripheral blood stem cell donor should be HLA allele level matched at A, B, C, and DR-B1. ... Minimum prefreezing cell dose for cord blood units: 3 x 10^7 total nucleated cells/kg and 1.5 x 10^5 CD34+ cells/kg (cluster of ... Busulfan. Vidarabine. Alkylating Agents. Antineoplastic Agents. Antimetabolites, Antineoplastic. Antimetabolites. Molecular ... Pulmonary: FEV1, FVC, and DLCO (corrected for hemoglobin) ≥40% of predicted; if unable to perform pulmonary function tests, ...https://clinicaltrials.gov/ct2/show/NCT02626715
Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders - Full Text View - ClinicalTrials.gov
Drug: Busulfan Administered every 6 hours: If , or = 12 kg then 1.1 mg/kg/dose intravenous (IV). If , 12 kg then 0.8 mg/kg/dose ... Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders. This study is ongoing, but not recruiting participants. ... Pregnant - menstruating females must have a negative serum pregnancy test within 14 days of treatment start ... 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight: The same dosage is ...https://clinicaltrials.gov/ct2/show/NCT01043640?recr=Open&cond=%22Adrenoleukodystrophy%22&rank=10
Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed...
HIGH-DOSE CHEMOTHERAPY: Adequate bone marrow function as evidenced by platelet count , 50,000/ul and absolute granulocyte count ... HIGH-DOSE CHEMOTHERAPY: Pretreatment tests and clinical and laboratory tests must have been performed within 4 weeks prior to ... This study is ongoing, but not recruiting participants. Sponsor:. City of Hope Medical Center ... prior bone marrow metastases with clearing of bone marrow (, 5% contamination as measured by bilateral bone marrow biopsies) at ...https://clinicaltrials.gov/ct2/show/NCT00638898?cond=%22Ewing+sarcoma%22&rank=15
Study of Etanercept for the Prevention of Complications Resulting From Hematopoietic Stem Cell Transplantation (HSCT) - Full...
GVHD is a common complication following a bone marrow transplant from another donor. GVHD occurs after transplant when the ... Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the ... The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) [ Time ... Patients must receive myeloablative regimen using fludarabine and busulfan. *For related donors: The donor and recipient must ...https://clinicaltrials.gov/ct2/show/NCT00141739
Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by...
ATG and low dose busulfan; and fludarabine and low dose TBI. Investigators have demonstrated the feasibility of this treatment ... Bone Marrow Diseases. Precancerous Conditions. Lymphoma. Lymphatic Diseases. Leukemia, B-Cell. Clofarabine. ... Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. ... 30 participants. Allocation:. Non-Randomized. Intervention Model:. Single Group Assignment. Masking:. None (Open Label). ...https://clinicaltrials.gov/ct2/show/study/NCT00697684?show_desc=Y