Phase II study of BSC-1 in patients with AT
- Conditions
- Adult T-cell leukemia/lymphoma
- Registration Number
- JPRN-jRCT2080224172
- Lead Sponsor
- Minophagen Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 38
1. Patients who were confirmed as positive for serum anti-HTLV-1 antibody and diagnosed with ATL and who were classified according to the lymphoma research group (LSG) classification as one of the following.
a) Smoldering type and chronic type not accompanied with unfavorable factor (indolent ATL).
b) Acute type, lymphoma type, or chronic type accompanied with unfavorable factor (aggressive ATL), or indolent ATL who achieved a response by more than one regimen of chemotherapy (include molecular targeted drugs) with history of acute transformation.
2. Patients who are 20 years of age or older on the date of obtaining consent to participate in the trial.
3. Patients with general condition score [Eastern Cooperative Oncology Group (ECOG) Performance Status] 0 to 2 at screening.
4. Patients whose major organs function are adequate
a) Patients with adequate renal function (eGFR: 60 mL/min/1.73 m^2 or more if the patient under 65 years old, 45 mL/min/1.73 m^2 or more if the patient 65 years old and over).
b) Patients with adequate liver function (AST, ALT and total bilirubin are less than 2.5 times the upper limit of the reference value).
c) Patients with adequate bone marrow function (hemoglobin 8 g/dL or more, neutrophil count 1,000 /uL or more, platelet count 50,000 /uL or more).
5. Patients with fasting serum triglycerides below 150 mg/dL or patients controlled to 150 mg/dL or less with drugs.
In the latter case, treatment with a drug for the treatment of dyslipidemia is continued without changing for 2 weeks or more before starting administration of the investigational drug, and the condition is stable.
6. About fertile female subjects:
The serum pregnancy test (beta-hCG) performed within 7 days before the start of study drug administration is negative.
And patients who were contraceptive by the effective methods for the period from 4 weeks before the negative result was obtained until the start of the investigational drug administration.
7. Patients who can agree to use adequate contraception, hormonal or barrier methods.
Fertile female subject:
During the study drug administration and for 1 month after completion of study drug administration.
Male subjects who have fertile partners:
During the study drug administration and for 3 months after completion of study drug administration.
8. Patient who agreed in writing about participation in this trial.
1. ATL patients with central nervous involvement.
2. Patients complicated with active cancer at screening.
3. Patients with HTLV-1 associated myelopathy (HAM) or HTLV-1 associated uveitis (HU).
4. Patient judged by investigator or clinical trial physician to be able to treat by skin-directed therapy.
5. Patients who are unlikely to survive for more than 24 weeks from the start of study drug administration.
6. Patients without lesions that can be evaluated by mSWAT at screening.
7. Patients who have been diagnosed with a skin disorder by a chemotherapy (including molecular targeted drugs) prior to the hospital visit for screening and who are judged by the investigator or the study doctor to have an impact on the evaluation of the drug.
8. Patients who were administered other investigational drugs within 12 weeks before starting study drug administration.
9. Pregnant patients, patients who may be pregnant, patients wishing for pregnancy, breastfeeding patients, or patients who can not accept appropriate contraceptive methods.
10. Patients with or having a history of hypersensitivity to the ingredients of the investigational drug or related preparations (retinoid).
11. Patients with history of pancreatitis or risk factors for pancreatitis.
12. Patients with severe complications or severe infections.
13. Patients with a history of serious allergies or severe drug hypersensitivity.
14. Patients who do not want to avoid or can not avoid long-time sunlight or UV light.
15. On other, patients judged not to be appropriate for participation in the trial by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method