A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen. - A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen. (ATL-NST-4)

Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.0 sites15 target enrollmentSeptember 8, 2008

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Enrollment: 15
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 8, 2008

End Date

August 1, 2013

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.

•(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.