Single-center, open-label, single-arm study study to investigate efficacy and safety of Hydroxychloroquine in ATLL patients
- Conditions
- Adult T-Cell Leukemia-LymphomaD015459
- Registration Number
- JPRN-jRCTs071220095
- Lead Sponsor
- Amano Masahiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
1 Age greater than or equal to18years
2 Patients with HTLV1 sero positive, pathologically and hematologically verified Adult Tcell leukemia lymphoma at diagnosis of peripheral lymphoid tumor with proven Tcell origin based on surface traits
3 Patients with any of the following types of ATLL
Patients with smoldering or chronic ATLL without poor prognostic factors without a history of acute transformation
4 Patients considered refractory to local treatment e.g. topical steroid therapy, ultraviolet light therapy, and radiation therapy.
5 Eastern Cooperative Oncology Group performance status of 0 to 2
6 Patients with preserved major organ function who meet the following criteria at screening;
Adequate renal function eGFR Upper 50mL per min per 1.73m2
Adequate liver function AST, ALT, and total bilirubin 2.5 x facility normal range
Adequate bone marrow function hemoglobin 8 g per dL or more, neutrophil count 1,000 per uL or more, platelet count 50000 per uL or more
7 For Fertile women
Confirmed negative with pregnancy test performed within 14 days prior to the start of study drug administration, and have used an effective method of contraception prior to the start of study drug administration.
8 For Fertile women
Patients who can agree to use effective method of contraception from screening to 3month after completion of study drug administration.
9 Patients who have given a written informed consent
1)Presence of CNS involvement with ATLL
2)Presence of complicated active cancer at screening
3)HAM or HAU patient
4)Life expectancy of less than 24 weeks from the start of study drug administration
5)No presence of mSWAT-evaluable lesion at screening
6)Patients who developed a skin disorder due to chemotherapy and have judged inadequate to evaluate the study drug
7) Patients who are using prohibited concomitant medications and who do not agree to the prohibition of concomitant use during the study period or for a specified period as indicated by the PI or SI.
8)Pregnant or possibly pregnant
9)History or suspected history of hypersensitivity to HCQ
10)Concurrent diagnosis of retinopathy or maculopathy, or history of these diseases
11)Concurrent diagnosis of serious complications or severe infections
12)Patients judged ineligible for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The best overall response up to 24 weeks using the mSWAT scores
- Secondary Outcome Measures
Name Time Method Efficacy<br>Disease control rate(DCR) by mSWAT<br>Response rate(best overall response)based on the partially modified ATLL response criteria<br>Duration of response by mSWAT<br>Time to response by mSWAT<br>Time to progression(TTP)by mSWAT<br>Duration of response based on the partially modified ATLL response criteria<br>Time to response based on the partially modified ATLL response criteria<br>DCR based on the partially modified ATLL response criteria<br>TTP based on the partially modified ATLL response criteria<br>Percentage of subjects with acute conversion<br>Time to acute conversion<br><br>Safety<br>Ratio of adverse events<br>Ratio of adverse drug reactions