Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

NCT ID: NCT05863234

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2026-03-31

Brief Summary

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This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.

Detailed Description

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Conditions

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Aggressive NK Cell Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with PPMX-T003

Group Type EXPERIMENTAL

PPMX-T003

Intervention Type DRUG

The therapeutic agent is administered continuously intravenously

Interventions

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PPMX-T003

The therapeutic agent is administered continuously intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.

Exclusion Criteria

* Patients eligible to receive chemotherapy as treatment for ANKL
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University Hospital

OTHER

Sponsor Role collaborator

Hokkaido University Hospital

OTHER

Sponsor Role collaborator

Okayama University

OTHER

Sponsor Role collaborator

Tokai University

OTHER

Sponsor Role collaborator

Kyushu University

OTHER

Sponsor Role collaborator

Tohoku University

OTHER

Sponsor Role collaborator

Nagoya University

OTHER

Sponsor Role collaborator

Komagome Hospital

OTHER

Sponsor Role collaborator

Hiroshima University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Kiyoshi Ando

Role: CONTACT

+81 82-257-5555

Facility Contacts

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Kiyoshi Ando

Role: primary

+81 82-257-5555

References

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Fukuhara N, Onizuka M, Kanda J, Asada N, Kato K, Ando K. Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia. BMJ Open. 2025 Jun 30;15(6):e098532. doi: 10.1136/bmjopen-2024-098532.

Reference Type DERIVED
PMID: 40588385 (View on PubMed)

Other Identifiers

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PPMX-T003-CT103

Identifier Type: -

Identifier Source: org_study_id

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