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.

UMIN ID: UMIN000000872

Registered date:01/11/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: (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).
• Date of first enrollment: 2007/11/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 toxicity. After completion of the 5th vaccination, patients are examined for 3 weeks for full evaluation. Follow-up period may be extended if necessary.

Outcome(s)

• Primary Outcome: (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: (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.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Aichi Cancer Center Research Institute
• Secondary Sponsor: None
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare,None