Adult T cell leukemia/lymphoma
Conditions
Interventions
Cord blood 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) Acute or lymphoma type ATL patients. (2) No suitable related donor, or no suitable unrelated bone marrow 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)ATL patients whose disease is controlled by the chemotherapy to CR or PR. (5) ECOG performance status 0 or 1. (6) Life expectancy beyond 3 months is anticipated by certain treatment. (7)Written informed consent from the patient. (8)Present of suitable single unit cord blood
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, melphalan), in GVHD prophylaxis (tacrorimus, MMF, steroids) and G-CSF. (7) Recipient of previous allogeneic hematopoietic stem cell transplantation. (8) Positive for HIV antibody. (9) Positive for HBs antigen. (10) Have an active cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival after transplantation at day 100 and achievement of engraftment after transplantation before day 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Over all survival 2)Disease free survival 3)Anti leukemia/lymphoma effect 4)Anti viral(HTLV-1) effect 5)Incidence and severity of GVHD 6)Other adverse event | — |
Countries
Japan
Contacts
Public ContactIlseung Choi
National Hospital Organization Kyushu Cancer Center Division of Hematology
Outcome results
None listed