NEWS HIGHLIGHTS
Published Studies Related to Busulfex (Busulfan)
Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. [2011.06]
Although a combination of i.v...
Randomized trial of two different conditioning regimens for bone marrow transplantation in thalassemia--the role of busulfan pharmacokinetics in determining outcome. [2005.11]
In total, 94 patients with homozygous beta thalassemia were randomized to two different conditioning regimens: busulfan 600 mg/m2 + cyclophosphamide 200 mg/kg or busulfan 16 mg/kg + cyclophosphamide 200 mg/kg and antilymphocyte globulin (47 in each group), for bone marrow transplantation, to see whether increased myeloablation or increased immunosuppression would reduce rejection...
Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. [2003.09]
Conditioning regimens for children with ALL have generally included total body irradiation (TBI), which may result in significant sequelae. The primary aim of this study was to evaluate the outcome for children with ALL undergoing allogeneic stem cell transplant (SCT) with either busulfan (Bu) or TBI regimens...
Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies. [2001.12.15]
In the early 1990s, 4 randomized studies compared conditioning regimens before transplantation for leukemia with either cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan (Bu) and CY. This study analyzed the long-term outcomes for 316 patients with chronic myeloid leukemia (CML) and 172 patients with acute myeloid leukemia (AML) who participated in these 4 trials, now with a mean follow-up of more than 7 years...
Increased risk of chronic graft-versus-host disease, obstructive bronchiolitis, and alopecia with busulfan versus total body irradiation: long-term results of a randomized trial in allogeneic marrow recipients with leukemia. Nordic Bone Marrow Transplantation Group. [1999.04.01]
Leukemic patients receiving marrow from HLA-identical sibling donors were randomized to treatment with either busulfan 16 mg/kg (n = 88) or total body irradiation ([TBI] n = 79) in addition to cyclophosphamide 120 mg/kg. The patients were observed for a period of 5 to 9 years... In patients with chronic myeloid leukemia (CML) in first chronic phase, 7-year LFS was 72% and 83% in the two groups, respectively.
Clinical Trials Related to Busulfex (Busulfan)
Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor [Active, not recruiting]
The purpose of this research study is:(1) to determine if high doses of chemotherapy without
total body irradiation can allow selected stem cells to take and grow,(2) to determine if
selected stem cells from the blood or marrow can take and not cause a complication called
graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of
chemotherapy drugs used for these transplants. In the last 10 years we have developed
chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using
three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good
chemotherapy combination to kill cancer cells, and to make the graft take, without the side
effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are
busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell
transplantation, but not given together as in this specific regimen. This is what is being
tested in this study.
Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the
overall results of the transplants were not better. The reason for this was that the stem
cells did not take and engraft in 15% of our adult patients. This failure of the stem cells
to take can leave patients without bone marrow or blood cells necessary for life. Most stem
cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we
give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem
cells (PBSC) and use them for transplant. The advantage of this approach is that we can
collect 2-20 times more stem cells than that obtained from the marrow. It has been proven
that a larger number of stem cells in the graft make it more difficult for the patient to
reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or
they may not want to take G-CSF shots. In these cases the donors will have their marrow
collected in the operating room under general anesthesia.
Stem cell transplants can lead to a condition known as acute graft-versus-host disease or
GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells)
of the donor (graft) against your body (the host). These T-cells see your body as foreign and
attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were
developed at this institution to prevent GvHD. These methods take out most of the T-cells
(responsible for GvHD) from the marrow or blood stem cells before transplant. This is called
"T-cell depletion" or "stem cell selection". In this hospital, we use two types of methods of
T-cell depletion: one method is used with peripheral blood stem cells and one for bone
marrow. Both these techniques have been successful in preventing both acute and chronic GvHD.
You will receive a T-cell depleted stem cell transplant.
Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation [Recruiting]
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)
followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine
in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin [Recruiting]
The goal of this clinical research study is to learn about the safety of AMD3100
(plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an
allogeneic blood stem cell transplant. This treatment will be studied in patients with AML,
MDS, or CML.
Objectives:
Primary Objective:
1. To determine the safety of Plerixafor and Filgrastim (G-CSF) in combination with
busulfan, fludarabine and allogeneic hematopoietic transplantation for treatment of
advanced myeloid leukemias.
2. Determine biologic effects of Plerixafor and G-CSF on leukemia cells.
3. To determine if the combination of Plerixafor and G-CSF with busulfan, fludarabine will
improve progression free survival post allogeneic stem cell transplantation from an
HLA-compatible donor compared to historical controls receiving busulfan-fludarabine
alone.
Secondary Objectives:
1. To determine the time to engraftment, the rate and severity of GVHD, and immune
reconstitution.
Busulfan in Multiple Myeloma [Recruiting]
Two main objectives of the study are:
Primary:
To determine the MTD of Busulfex ® that can be given safely over the least number of days to
myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency
(Group 2), defined as creatinine >3mg/dL or creatinine clearance <30 mL/min.
Secondary:
To perform pharmacokinetic (PK) studies to evaluate individual variability and the
relationship to toxicities in each of the two groups at each proposed dose level.
Reports of Suspected Busulfex (Busulfan) Side Effects
Venoocclusive Liver Disease (14),
Acute Graft Versus Host Disease (13),
Chronic Graft Versus Host Disease (13),
Renal Failure (13),
Thrombotic Microangiopathy (12),
Acute Respiratory Distress Syndrome (8),
Pleural Effusion (8),
Mucosal Inflammation (8),
Cytomegalovirus Infection (8),
Graft Versus Host Disease (7), more >>
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