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.
- 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 >=3CR/non-CR or any AML with M0/M6/M7 FAB type, ALL in >=2CR/non-CR, CML in >=2CP or >=AP, Multiple Myeloma in PD, NHL in non-CR).
- Registration Number
- JPRN-UMIN000000872
- Lead Sponsor
- Aichi Cancer Center Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 12
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (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 Outcome Measures
Name Time Method (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.