JPRN-jRCTs031200375
Recruiting
Phase 2
Phase II study to evaluate efficacy and safety of unrelated peripheral blood stem cell transplantation with post-transplant cyclophosphamide for adult T-cell leukemia/lymphoma
Fukuda Takahiro0 sites24 target enrollmentMarch 1, 2021
Conditionsadult T-cell leukemia/lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- adult T-cell leukemia/lymphoma
- Sponsor
- Fukuda Takahiro
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adult T\-cell leukemia/lymphoma, acute or lymphoma type
- •2\) Patients who have an HLA 6\-8/8 matched unrelated peripheral blood stem cell donor
- •3\) Age: 20\-65 years old
- •4\) ECOG performance status: 0 or 1
- •5\) Disease status: CR, PR, or, SD
- •6\) Written informed consent from the patient
- •7\) Patients who are expected to survive for at least 3 months
Exclusion Criteria
- •1\) Severe organ dysfunction in the heart, lung, kidney, or liver
- •2\) Uncontrollable ATL lesion in central nervous system
- •3\) Uncontrollable diabetes mellitus
- •4\) Uncontrollable hypertension
- •5\) Coronary artery disease requiring treatment, cardiomyopathy, cardiac failure, or arrhythmia requiring medication
- •6\) Acute hepatitis, chronic active hepatitis, or liver cirrhosis
- •7\) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest X\-ray.
- •8\) Infectious disease requiring systemic therapy
- •9\) Simultaneous or metachronous (within 5 years) double cancers, except for carcinoma in situ resected by local therapy
- •10\) History of lymphoma, myelodysplastic syndrome, or leukemia
Outcomes
Primary Outcomes
Not specified
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