UMIN ID: UMIN000001355
Registered date:08/09/2008
A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Adult T cell leukemia/lymphoma |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 15 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen. |
Outcome(s)
| Primary Outcome | Survival after transplantation at day 100 and achievement of complete chimera after transplantation before day 100. |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 50years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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) Have an active cancer. |
Related Information
| Primary Sponsor | Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ilseung Choi |
| Address | 3-1-1 Notame Minami-ku Fukuoka-city, Japan Japan |
| Telephone | 092-541-3231 |
| ilchoi@nk-cc.go.jp | |
| Affiliation | National Hospital Organization Kyushu Cancer Center Division of Hematology |
| scientific contact | |
| Name | Jun Okamura |
| Address | 3-1-1 Notame Minami-ku Fukuoka-city, Japan Japan |
| Telephone | 092-541-3231 |
| jyokamur@nk-cc.go.jp | |
| Affiliation | National Hospital Organization Kyushu Cancer Center Division of Clinical Research |