Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation.

Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation. - Prevention or Treatment of Recurring Malignancies after Allongeneic Transplantation with Minor Antigen Peptides

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000872

Enrollment

Registered

2007-11-01

Start date

2007-11-01

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

(1) Therapeutic vaccine: Any hematological malignancies recurred after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML, ALL, CML, Multiple Myeloma, NHL). (2) Prophylactic vaccine: Hematological malignancies with high risk of relapse after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML in &gt

Interventions

Cohorts of 3-6 patients with disease recurrence (for treatment) or with high risk of disease relapse (for prevention) wreceive escalating doses (4 steps

0.03mg, 0.3mg, 1.0mg, 3.0mg) of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are planned to receive allogeneic hematopoietic cell transplantation or post-transplant patients. (2) Patients positive for HLA-A*24:02 (in case of ACC-1 minor antigen); HLA-B*4402 or B*44:03 (in case of ACC-2 minor antigen); HLA-A*02:01 or A*02:06 (in case of HA-1 minor antigen), HLA-B*4402 or B*44:03 (in case of ACC-6 minor antigen). Patients receiving 1>= eligible minor antigen-mismatched (listed above) transplant. (3) Preserved major organ function. (4) WHO performance status between 0 and 2. (5) Written informed consent. (6) More than 60 days after transplant for the first vaccination.

Exclusion criteria

Exclusion criteria: (1) CNS involvement or uncontrollable extramedullary disease. (2) Severe infections (including active tuberculosis) or double cancer. (3) Patients treated with major tranquilizer or antidepressant. (4) One of the following: positive HBs antigen, seropositive to HCV, seropositive to HIV, seropositive to HTLV-1, seropositive to STS. (5) Other reasons not eligible for vaccination (decision by physicians). (6) Past history of acute GVHD >= grade 3. (7) With more than grade 3 non-hematological toxicity at 10 days prior to vaccination. (8) Within 10 days after previous chemotherapy and neutrophil counts less than 200/mm^3. (9) On corticosteroid treatment. (10) Lack of availability for immunological and clinical follow-up assessments.

Design outcomes

Primary

Measure	Time frame
(1) Frequencies of acute GVHD greater than grade 3, or extensive chronic GVHD with 13 days after the last (5th) vaccination. (2) Frequencies of non-hematological toxicity greater than grade 3 by NCI-CTC criteria.	—

Secondary

Measure	Time frame
(1) Complete remission rate within 3 weeks after the last (5th) vaccine (in therapeutic settings only). (2)Immune responses by flowcytomeric analysis (tetramer or cytokine production) and DTH after vaccine completion and duration of immune response. (3)Tolerable maximal dose of vaccine.	—

Countries

Japan

Contacts

Public ContactHirofumi Taji

Aichi Cancer Center Center Hospital Department of Hematology & Cell Therapy

men-ekiryoho@aichi-cc.jp052-762-6111

Outcome results

None listed

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