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Open-labeled, non-randomized, single institute study of dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies

Open-labeled, non-randomized, single institute study of dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies - Dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028456
Enrollment
25
Registered
2017-07-31
Start date
2009-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological malignancies

Interventions

Sponsors

Sapporo Hokuyu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with refractory or relapsed hematological malignancies 2. Performance Status; 0-2 3. Survival period is expected more than 4 months 4. HLA-A*2402, 0201 or 0206 positive 5. Meet the following criteria for organ functions 1) WBC more than 2,500/microliter, Hemoglobin more than 9.0 g/dl, Platelet more than 90,000/microliter 2) Serum AST/ALT less than 2.5 folds of the upper normal limit 3) Serum bilirubin less than1.5 folds of the upper normal limit 4) Serum Albumin more than 3.0g/dl 5) Serum creatinine within normal limitation 6) No serious ECG abnormality 6. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells. 7. Informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1. There is deep-seated active infection. 2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered inappropriate for the trial. 4. There are other malignancies. 5. Pregnant or lactating woman. 6. Past history of severe drug allergy. 7. There is severe psychiatric disease. 8. The patient is considered inappropriate for the trial by a responsible doctor.

Design outcomes

Primary

MeasureTime frame
Adverse events, Immunological response, Efficacy

Secondary

MeasureTime frame
Progression free survival, Overall survival

Countries

Japan

Contacts

Public ContactIkumi Yamada

Sapporo Hokuyu Hospital Cellular Immunotherapy Center

i.yamada0414@hokuyu-aoth.org011-865-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026