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) Written informed consent from the patients or their legal guardians (under 20 years old). 7) No other complications not suitable for transplantation. 8) 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