hematologic malignancies
Conditions
Interventions
The radiation dose will be escalated according to the predefined protocol to evaluate safety. Five dose levels (Level -1 to Level 4) are planned, and treatment will commence at Level 1. Depending on t
Sponsors
Murofushi Keiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, chronic myeloid leukemia, Hodgkin lymphoma, or non-Hodgkin lymphoma, who are considered medically eligible for allogeneic hematopoietic stem cell transplantation and undergoing their first allogeneic transplantation. 2. Patients considered to be at high risk for standard conditioning regimens, defined as those aged >= 50 years at the time of transplantation and/or with a Hematopoietic Cell Transplantation - Comorbidity Index score >2. 3. ECOG Performance status of 0 - 2. 4. Adequate function of major organs within 28 days prior to study enrollment and met the following a)-h) criteria. a) Echocardiogram : Left ventricular cardiac ejection fraction of >= 50%. b) 12-lead electrocardiogram : No abnormal findings that require treatment. c) Arterial oxygen saturation >= 94% without inhaling oxygen. (Measurement by non-invasive oxygen saturation monitoring is also acceptable.) d) Pulmonary function test: %VC >= 70% and FEV1/FVC >= 70%. e) Serum total bilirubin == 30 mL/min. Predicted values based on Cockcroft-Gault equation are also acceptable. g) No diabetes mellitus poorly controlled with insulin. h) No psychiatric disorders requiring treatment with a major tranquilizer. 5. Written informed consent is obtained. If the case of a minor, the consent of a surrogate must be obtained.
Exclusion criteria
Exclusion criteria: 1. Patients not met the inclusion criteria. 2. Extramedullary or extranodal disease. 3. Synchronous or metachronous (within 5 years) malignancies. 4. Difficulty in maintaining rest during radiation therapy. 5. Patients who are technically difficult to irradiate with TomoTherapy (cannot fit in the treatment gantry, overweight, or difficult to calculate the dose). 6. Pregnant or potentially pregnant patients. 7. History of allogeneic or autologous transplantation. 8. Patients determined to be intolerant to hematopoietic stem cell transplantation, including chemotherapy and TMLI as a conditioning regimen. 9. Other conditions judged as inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity up to 28 days after hematopoietic stem cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil/platelet engraftment rate, Overall survival, Relapsed rate, Non-relapse mortality rate, Incidence of acute GVHD of Grade II-IV, Incidence of chronic GVHD | — |
Contacts
Public ContactYuho Najima
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital
Outcome results
None listed