Total-Body Irradiation for Myelodysplastic Syndromes
This study is evaluating whether a combination of chemotherapy and total body irradiation before a stem cell transplant works better than chemotherapy and total body irradiation before a stem cell transplant.
See full descriptionAbout the trial for Myelodysplastic Syndromes
Treatment Groups
This trial involves 2 different treatments. Total-Body Irradiation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex of any age. You must have received 1 prior treatment for Myelodysplastic Syndromes or one of the other 17 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Total-Body Irradiation will improve 1 primary outcome and 7 secondary outcomes in patients with Myelodysplastic Syndromes. Measurement will happen over the course of Baseline and at day 0 within 6 hours of conditioning prior to transplant.
Who is running the study
Principal InvestigatorPatient Q & A Section
What is myelodysplastic syndromes?
The MDS diagnostic criteria for the WHO require the presence of one or more of the following 3 features: \n• ≤ 35% blasts in blood and/or bone marrow,\n• ≤ 35% platelet count,\n• > 100 x 10/l in peripheral blood blasts\n\nThis presentation consists of 5 criteria: \n• Cytological features,\n• Cytological features\n• Cytogenetic abnormalities,\n• Unfavourable haematological features\n• Cytogenetic abnormalities\n\nMDS may be associated with or caused by a number of identifiable genes, such as the 5q- and 7q- chromosome abnormalities.
Can myelodysplastic syndromes be cured?
MDS cannot be cured, but some have shown improvement and some have stopped disease progression with appropriate treatment. Patients with MDS are more likely to have improved symptoms with treatment.
How many people get myelodysplastic syndromes a year in the United States?
Around 10.4 million individuals are diagnosed with at least one myelodysplastic syndrome in the United States each a year. This makes up 2.7% of American adults.
What are the signs of myelodysplastic syndromes?
The presenting history is important and should include the date of onset, the frequency and duration of changes in the disease course, and whether any associated symptoms are present. A full blood count is helpful as well as further testing for erythropoietin resistance.
What are common treatments for myelodysplastic syndromes?
The use of conventional cytotoxic therapy and peripheral blood stem cell transplant as well as autologous stem cell transplant, are common treatments for MDS. Other options for treatment of refractory disease in selected patients, including immunomodulation, anti-angiogenic agents and the application of agents directed against JAK/STAT signalling have been described in the treatment of MDS.
What causes myelodysplastic syndromes?
The aetiology of MDS is not understood, but some factors may be modifiable. Dietary supplementation with folate and vitamin B12 might protect people with MDS against progression to acute myeloid leukemia.
What is the average age someone gets myelodysplastic syndromes?
The average age at diagnosis of MDS in Scotland is 67.2 years, with an increase in the proportion of patients diagnosed at more advanced ages from the 1990s to the current decade. The proportion of patients over the age of 70 years had increased over the period 1994-2014, irrespective of diagnosis criteria or method of referral, and increased by an average 4.7 years compared with a similar period in 2003-04. The age distribution of MDS is progressively changing in Scotland. The data have important implications for the management of patients with MDS, their prognosis and potential treatment.
Who should consider clinical trials for myelodysplastic syndromes?
Allogeneic stem cell and hematopoietic stem cell transplantation, as well as bone marrow and intraconventional procedures (allogeneic stem cell transplant, autologous stem cell transplantation, chemoablation, and nonmyeloablative allopurinol hyperbaric treatment are the therapeutic modalities used for treatment of MDS). However, all these modalities have significant toxicity in terms of hematopoietic or nonhematopoietic toxicity. The clinical trial for myelodysplastic syndromes should be tailored according to the MDS subtype.
How quickly does myelodysplastic syndromes spread?
The spread of MDS to other body sites is rare after the initial onset, probably because of the blood-lymphatic barrier, and because of the limited capacity of MDS for spreading to other places by way of the blood stream.
Does myelodysplastic syndromes run in families?
MDS run in families. Families with MDS should be offered genetic counselling when appropriate. Genetic counselling was provided to all members of one family. Genetic counselling is appropriate, for families with MDS, as many members have inherited at least one pathogenic MDS gene mutation.
What are the chances of developing myelodysplastic syndromes?
Myelodysplastic syndromes are relatively rare, but they can be a problem if they develop into acute myeloid leukemia. Those with a positive family history generally have a better prognosis than those without a family history.
What is the survival rate for myelodysplastic syndromes?
The median (or mid-term) survival rate for MDS in the general population is about 10 years. The 5-year survival rate is 40.2%, while the 10-year survival rate is 15.9%. The relative survival rate is 0.56 at 5 years and 0.50 at 7 years. These survival rates reflect patients with a diagnosis of MDS at a time when they are no longer at risk for developing myelodysplastic syndromes. Survival rates for patients diagnosed with MDS at an earlier time, as they approach the aging population, are probably similar to those for the general population.