A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.

UMIN ID: C000000409

Registered date:01/05/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Adult T cell leukemia/lymphoma
• Date of first enrollment: 2006/03/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.

Outcome(s)

• Primary Outcome: Over all survival rate at 2 years after transplantation.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 70years-old
• Gender: Male and Female
• 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) Uncontrollable disease by the chemotherapy. (11) Have an active cancer. (12) Patients evident negative monoclonality of HTLV-1 by southern blot analysis.

Related Information

• Primary Sponsor: Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan
• Source(s) of Monetary Support: Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.