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Recruiting NCT07075328

A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma

Phase I / Phase II Interventional Adult T-Cell Leukemia/Lymphoma (ATLL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug:5-ALA, Device:Photodynamic system.
Who it may be relevant to
Registry conditions: Adult T-Cell Leukemia/Lymphoma (ATLL). Basic parameters: 20 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.

Overview

This study aims to evaluate the tolerability of OJP-001, a therapeutic system combining photodynamic therapy (PDT) using OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study will also investigate the recommended dose and pharmacokinetics of OMD-001, as well as the efficacy and safety of OJP-001.

Detailed description

\[Phase I part\] 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.

Interventions

  • Other Drug:5-ALA, Device:Photodynamic system
    \[Phase I part\] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive Photodynamic system 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 Photodynamic system once a week for 6 months.

Primary outcome measures

  • Phase I part: Dose limiting toxicity [Time frame: Phase I part: 2 weeks]
  • Phase II part: Response rate (best overall response) [Time frame: Phase II part: 24 weeks]

Eligibility criteria

Inclusion criteria

  • 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)
  • Age: 20-85
  • 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
  • Relapsed or recurrent ATL judged inadequate of treatment with mogamulizumab by investigators
  • Relapsed or recurrent ATL after allogeneic hematopoietic stem cell transplantation
  • Having peripheral blood lesion
  • ECOG performance status: 0-2
  • T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5
  • Expected more than 3 months of survival

Exclusion criteria

  • Body Weight < 35kg
  • Hemoglobin < 10g/dL
  • Splenomegaly
  • 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
  • Administrated 5-ALA drug except study drug within 7 days prior to registration
  • Ate the foods containing 5-ALA or St. John's wort within 7 days prior to registration
  • Synchronous or metachronous malignancy
  • Uncontrolled severe complications
  • Porphyria
  • Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV)
  • Uncontrolled inter-current illness including: heart failure, kidney failure, liver failure, hypertension, diabetes mellitus
  • Psychological disorder (mental illness, dementia, depression)
  • HBs-Ag positive or HBc-Ab positive with HBV-DNA positive
  • HCV-Ab positive
  • HIV-Ab positive
  • CNS involvement at screening
  • QTcF > 470ms at screening
  • Uncontrolled intercurrent infection
  • Pregnant or nursing women
  • During participated in other clinical trials
  • Other inadequate conditions determined by investigators
  • In phase II part: subjects who registrated in phase I part of this trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 5 centers
  • National Kyushu Cancer Center — Fukuoka
  • Sapporo Hokuyu Hospital — Sapporo
  • Imamura general hospital — Kagoshima
  • University of Miyazaki Hospital — Miyazaki
  • Nagasaki University Hospital — Nagasaki

Identifiers

NCT: NCT07075328 · PDT-21-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗