Adult T-Cell Leukemia-Lymphoma Adult T-Cell Leukemia-Lymphoma
Conditions
Interventions
Drug: Hydroxychloroquine
Oral administration, 24weeks
For an ideal weight less than or equal to31 kg and greater than 46 kg: 200 mg once a day, For an ideal weight less than or equal to 46 kg and les
Sponsors
Mochida Kosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The best overall response up to 24 weeks using the mSWAT scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Disease control rate(DCR) by mSWAT Response rate(best overall response)based on the partially modified ATLL response criteria Duration of response by mSWAT Time to response by mSWAT Time to progression(TTP)by mSWAT Duration of response based on the partially modified ATLL response criteria Time to response based on the partially modified ATLL response criteria DCR based on the partially modified ATLL response criteria TTP based on the partially modified ATLL response criteria Percentage of subjects with acute conversion Time to acute conversion Safety Ratio of adverse events Ratio of adverse drug reactions | — |
Contacts
Public ContactKosuke Mochida
University of Miyazaki Hospital
Outcome results
None listed