JPRN-C000000162
Unknown
Phase 1
Phase I/II study of adoptive immunotherapy using cytotoxic T cells specific for minor histocompatibility antigen restricted to hematopoietic cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation - Cellular adoptive immunotherapy using CTL specific for hematopoietic-lineage minor histocompatibility antigen for the treatment of patients with relapsed leukemia following transplantation.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 1) RAEB, CMML 2) AML or ALL in induction failure or beyond first remission 3) Ph/p190-positive ALL at any stage 4) imatinib-resistant CM
- Sponsor
- Aichi Cancer Center
- Enrollment
- 30
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) CNS involvement or uncontrollable extramedullary disease. 2\) Severe infections (including active tuberculosis) or double cancer 3\) Patients with organ toxicity as follows: (a) T.Bil \>\= 1\.5 mg/dl, (b) GOT, GPT \>\= 2\.5 x N (upper normal limit of individual institutions), (c) serum creatine \>\= 1\.5 x N, 24\-h Ccr \=\< 60 ml/min, (d) PaO2 \< 60 mmHg, (e) ejection fraction \<50%, (f) abnormal ECG (ischemic change or arrhythmia requiring treatment) 4\) Uncontrolable HT 5\) One of the following: positive HBs antigen, seropositive to HCV, seropositive to HIV, seropositive to HTLV\-1, seropositive to STS 6\) Patients treated with major tranquilizer or antidepressant 7\) Patients inappropriate for transplantation with reasons other than above.
Outcomes
Primary Outcomes
Not specified
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