Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .

Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies . - Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008823

Enrollment

Registered

2012-08-31

Start date

2012-09-01

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 malignancy

Interventions

The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vacci

s adjuvant every week (3.0 mg/each peptide

6 times/cycle). If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue .

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as hematological malignancy resistant to standard therapies. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types. 4)Patients must be expected to survive more than 3 months. 5) Patient's laboratory data must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dl Platelet is more than 80,000/mm3 Serum Creatinine is less than 2 times the ULN Total bilirubin are less than 2 times the ULN.(However, 2.5 or less times in the case of the patient of constitutional jaundice.) 6) Patients must be more 18 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1) Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al). 2) Patients with the past history of severe allergic reactions. 3) (Females) Pregnant or nursing patients. Patients desiring future fertility. (Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 4) Patients who are judged inappropriate for entry to this clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Immune-enhancing effects (changes in anti-peptide IgG titers in plasma)	—

Secondary

Measure	Time frame
1.Analyze the correlation between enhancement of peptide specific antibody and all over survival. 2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

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