NEWS HIGHLIGHTSMedia Articles Related to Myleran (Busulfan)
busulfan-oral, Myleran
Source: MedicineNet Peripheral Blood Stem Cell Transplant Specialty [2005.03.02]
Title: busulfan-oral, Myleran
Category: Medications
Created: 3/2/2005
Last Editorial Review: 3/2/2005
busulfan-injection, Busulfex
Source: MedicineNet Peripheral Blood Stem Cell Transplant Specialty [2005.03.02]
Title: busulfan-injection, Busulfex
Category: Medications
Created: 3/2/2005
Last Editorial Review: 3/2/2005
Published Studies Related to Myleran (Busulfan)
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.
A long term follow-up of a randomized trial comparing interferon-alpha with busulfan for chronic myelogenous leukemia. The Kouseisho Leukemia Study Group. [1998.09]
To evaluate the long-term effectiveness of interferon-alpha (IFN-alpha) therapy in patients with chronic myelogenous leukemia (CML) in chronic phase, we examined the updated outcomes of 159 patients who had been enrolled between 1988 and 1991 into a randomized trial comparing IFN-alpha with busulfan...
Clinical Trials Related to Myleran (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.
UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients [Active, not recruiting]
The purpose of this study is to find out if patients with high risk disease because of age or
kidney status can be treated more safely with a drug called Busulfex® followed by autologous
transplant compared to treatment with the standard drug called melphalan, which has been
shown to be quite difficult to tolerate in patients with poor kidney function and patients
over the age of 65 when given in high doses.
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT [Completed]
The primary objective of this study is to assess the safety and efficacy of performing
unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative
therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to
demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40%
at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to
demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.
Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population [Recruiting]
Recently, several conditioning regimens did not include total body irradiation (TBI)
anymore, especially in the case of young children due to cognitive sequelae and late effects
on growth and height. Thus, such effective chemotherapy conditioning regimens were developed
to avoid these complications. Busulfan is one of the major drugs used in these treatments,
but, is also administered in high dose chemotherapy followed by autograft. In both
situations, long term pulmonary side effects were diagnosed in a few cases. Even if the
occurrence is not very frequent, the clinical management is a real challenge regarding the
reduced quality of life and life expectancy of these patients. Up to now, no correlation was
done between respiratory sequelae and busulfan pharmacokinetics. Hence, in the
investigators' pediatric onco-hematological unit, a prospective study will begin and last
three years to assess the respiratory side effects due to busulfan and their potential links
with individual drug pharmacokinetic measures. These results will be compared to patients
treated with TBI during the same period of time.
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT) [Recruiting]
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days - 6, - 5, -4, and -3. Daily treatment doses will be adjusted to achieve target AUCs (area under
the plasma concentration time curve). Day 0 is the day of hematopoietic progenitor cell
reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be
collected for dose modification based on the AUC levels. Dose escalation will proceed to
determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit
of higher doses of busulfan.
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