Single-center, open-label, single-arm study study to investigate efficacy and safety of Hydroxychloroquine in ATLL patients

JRCT ID: jRCTs071220095

Registered date:26/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult T-Cell Leukemia-Lymphoma
• Date of first enrollment: 24/05/2023
• Target sample size: 5
• Study type: Interventional

Intervention(s)

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 less than 62 kg:
200 mg once a day and 400 mg once a day, every other day
For an ideal weight greater than or equal to 62 kg: 400 mg once a day

Outcome(s)

• Primary Outcome: The best overall response up to 24 weeks using the mSWAT scores

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Amano Masahiro