Evaluating the safety of PPMX-T003 for aggressive NK-cell leukemia
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
PHASE1; PHASE2 · Hiroshima University Hospital · NCT05863234
This study is testing a new drug called PPMX-T003 to see if it is safe and effective for people with aggressive NK-cell leukemia.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hiroshima University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hiroshima, Hiroshima) |
| Trial ID | NCT05863234 on ClinicalTrials.gov |
What this trial studies
This is a Phase I/II dose-escalation study designed to assess the tolerability, safety, efficacy, and pharmacokinetics of the investigational drug PPMX-T003 in patients with aggressive NK-cell leukemia. The study will include patients diagnosed with this condition, regardless of whether it is their first occurrence or a recurrence. The trial aims to gather data on how well the drug works and its safety profile in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with aggressive NK-cell leukemia who are not eligible for chemotherapy.
Not a fit: Patients who are eligible to receive chemotherapy for their aggressive NK-cell leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from aggressive NK-cell leukemia.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating other forms of leukemia with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hiroshima, Hiroshima
- Hiroshima University Hospital — Hiroshima, Hiroshima, Japan (RECRUITING)
Study contacts
- Study coordinator: Kiyoshi Ando
- Email: andok@keyaki.cc.u-tokai.ac.jp
- Phone: +81 82-257-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aggressive NK Cell Leukemia, neoplasms