JPRN-jRCT1032230247
Recruiting
Phase 2
A phase II Study of total marrow and lymphoid irradiation with intensity modulated radiotherapy using TomoTherapy
Murofushi Keiko0 sites28 target enrollmentJuly 20, 2023
Conditionsmalignant hematological diseases
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- malignant hematological diseases
- Sponsor
- Murofushi Keiko
- Enrollment
- 28
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Disease status is non\-remission period, or predicted poor prognosis equivalent to High / Very high on the Refined disease risk index.
- •2\. Aged from 16 to 59 years old.
- •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 \=\< 2\.0 mg/dL AND AST and ALT \=\< 5 x upper limit of normal.
- •f) Creatinine clearance \>\= 30 mL/min. Predicted values based on Cockcroft\-Gault equation are also acceptable.
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.
Outcomes
Primary Outcomes
Not specified
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