Adult T cell leukemia/lymphoma
Conditions
Interventions
Peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Sponsors
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) ATL patients whose disease is controlled by the chemotherapy to CR, PR or NC status. (2) HLA matched related donor. (3) Patient must fulfill the following criteria; 1.Age is between 50 and 70 years. 2.A patient ranging age 20 to 49 years is eligible if he (she) fulfills one or more criteria of organ dysfunction described bellow (a) to (d). (a) Resting ejection fraction between 50 and 60% by UCG. (b) SaO2 90 to 95% in room air. (c) Serum Cr level between 1.5 mg/dL and 2.0 mg/dL. (d) T.Bil level between 1.5mg/dL and 2.0 mg/dL or GPT over 3 times of upper limit, under 4 times. (4) ECOG performance status 0 or 1. (5) Written informed consent from the patient. (6) Life expectancy beyond 3 months is anticipated by certain treatment.
Exclusion criteria
Exclusion criteria: (1) A patient is uneligible if he (she) has (a) to (d). (a) Resting ejection fraction bellow 50% by UCG. (b) SaO2 bellow 90% in room air. (c) Serum Cr level above 2.0 mg/dL. (d) CCr bellow 20 mL/min/m2. (e) T.Bil level above 2.0 mg/dL or GPT over 4 times of upper limit. (2) Uncontrollable active infection. (3) Active CNS lesion at registration. (4) Woman who is pregnant, possibly pregnant or breast feeding (5) On or taking major tranquilizer, antidepressant, antimanic. (6) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, buslufan), in GVHD prophylaxis (Cyclosporine, steroids) and G-CSF. (7) Recipient of previous allogeneic hematopoietic stem cell transplantation. (8) Positive for HIV antibody. (9) Positive for HBs antigen. (10) Uncontrollable disease by the chemotherapy. (11) Have an active cancer. (12) Patients evident negative monoclonality of HTLV-1 by southern blot analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over all survival rate at 2 years after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Over all survival and progression free survival rate at 100 day after transplantation (at d100). 2.Achievement of complete chimera (Donor derived cell above 90% at d90). 3.Over all survival rate at d180 4.Over all survival and progression free survival rate at d365. 5.Progression free survival at 2 year after transplantation. 6.Time to progression and survival. 7.Toxicity due to conditioning regimen and drugs for acute GVHD prophylaxis. 8.Incidence and Severity of GVHD. 9.Relationship between time to onset of GVHD and chimera. 10.Retationship of GVHD, and anti tumor effect, overall survival or progression free survival rate. 11.Incidence of relapse and Infectious disease. 12.Anti viral (HTLV-1) effect. 13.Relationship between donor status for HTLV-1 infection (carrier or non-carrier) and anti tumor effect or anti viral effect. 14.Effectiveness and toxicity of donor lymphocyte infusion for mixed chimera. 15.Anti ATL effect of discontinuation of immunosuppressant after relapse of the disease. | — |
Countries
Japan
Contacts
Public ContactIlseung Choi
National Hospital Organization Kyushu Cancer Center Division of Hematology
Outcome results
None listed