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 CML
Conditions
Sponsors
Aichi Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed of one of the following type of leukemia: (a) RAEB, CMML, (b) AML or ALL in induction failure or beyond first remission, (c) Ph/p190-positive ALL at any stage, (d) imatinib-resistant CML 2) Aged 18 to 65 years 3) Sufficient organ function 4) ECOG PS 0-2 at time of enrollment 5) Patients receiving their first transplantation 6) Donor-patient pairs possessing appropriate disparity in predetermined minor histocompatibility antigens and restriction HLA alleles (i.e., BCL2A1/A24, HA-1/A*0201). 7) Written informed consent from the patients or their legal guardians (under 20 years old). 8) No other complications not suitable for transplantation. 9) Eligibility criteria at time of CTL infusion: (a) Patients with relapse at least 60 days after transplantation. (b) CTL clones must have been generated and have completed QC testing before treatment. (c) Relapsed leukemia as clearly defined by 1 or more of the following: morphologic relapse, cytogenetic relapse, molecular relapse. (d) Patients with >= grade III acute GVHD after transplantation. Patients with >= grade II acute GVHD or extensive chronic GVHD after cessation of immunosuppressive drugs other than maintenance dose of steroid. (e) No non-hematopoietic organ toxicity >= grade 3 one week prior to CTL infusion (NCI-CTC). (f) Neutrophil counts >= 200/ul at least 10 days after completion of cytoreductive chemotherapy.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Determine the toxicity including grade II or more acute GVHD from the initiation of T cell infusion to 2 weeks after the last infusion and extensive chronic GVHD. 2) Determine the non-hematological toxicity (grade 3 or 4) from the initiation of T cell infusion to 2 weeks after the last infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Determine the CR rate from the initiation of T cell infusion to 2 weeks after last infusion. 2) Determine the persistence and kinetics of transfused T cells in vivo from the initiation of T cell infusion to 2 weeks after last infusion. 3) Determine the T cell number that can be infused safely. | — |
Countries
Japan
Contacts
Public ContactYoshiki Akatsuka, M.D.,Ph.D
Aichi Cancer Center Division of Immunology, Department of Cell Therapy and Hematology
Outcome results
None listed