A phase I/II study of OJP-001 in patients with adult T-cell leukemia/lymphoma

JRCT ID: jRCT2071240003

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia/lymphoma
• Date of first enrollment: 01/04/2024
• Target sample size: 49
• Study type: Interventional

Intervention(s)

[Phase I part]
Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once.
Dosage of 5-ALA: 10 mg/kg (1st cohort), 20 mg/kg (2nd cohort), 40 mg/kg (3rd cohort), 60 mg/kg (4th cohort)
[Phase II part]
Patients will receive 5-ALA and OJP-001 once a week for 6 months.

Outcome(s)

Primary Outcome

Phase I part: dose limiting toxicity
Phase II part: response rate (best overall response)

Secondary Outcome

Phase I part: pharmacokinetics, safety, response in the peripheral blood lesions
Phase II: response rate, survival rate, overall survival rate, overall survival, response rate in each lesion, response duration, disease control rate, time to response, progression free survival, response in the peripheral blood lesions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acute, lymphoma type, or chronic type with unfavorable factor)
2) Age: 20-85
3) Meeting the any following criteria for screening
*Relapsed or recurrent ATL have history of treatment with mogamulizumab
*At least one regimen of chemotherapy in case of intolerance/contraindication for mogamulizumab
4) Having peripheral blood lesion
5) ECOG performance status: 0-2
6) T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5
7) Expected more than 3 months of survival

Exclude criteria

1) Body Weight < 35kg
2) Hemoglobin < 10g/dL
3) Splenomegaly
4) Subjects who received an following therapy
*Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration
*Radiotherapy : within 28 days prior to registration
*Any investigational drugs or medical devices (unapproved in Japan) : within 28 days prior to registration
*Autologous stem cell transplantation : within 84 days prior to registration
*Allogenic stem cell transplantation : within 100 days prior to registration
5) Administrated 5-ALA drug except study drug within 7 days prior to registration
6) Ate the foods containing 5-ALA or St. John's wort within 7 days prior to registration
7) Synchronous or metachronous malignancy
8) Uncontrolled severe complications
9) Porphyria
10) Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV)
11) Uncontrolled inter-current illness including: heart failure, kidney failure, liver failure, hypertension, diabetes mellitus
12) Psychological disorder (mental illness, dementia, depression)
13) HBs-Ag positive or HBc-Ab positive with HBV-DNA positive
14) HCV-Ab positive
15) HIV-Ab positive
16) CNS involvement at screening
17) QTcF > 470ms at screening
18) Uncontrolled intercurrent infection
19) Pregnant or nursing women
20) During participated in other clinical trials
21) Other inadequate conditions determined by investigators
22) In phase II part: subjects who registrated in phase I part of this trial

Related Information

• Primary Sponsor: Shiobara Noriyuki