JCOG0907: Phase II trial for the strategy including allogeneic hematopoietic stem cell transplantation using myeloablative conditioning for adult T-cell leukemia-lymphoma

JRCT ID: jRCTs031180243

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: adult T-cell leukemia-lymphoma
• Date of first enrollment: 12/03/2019
• Target sample size: 110
• Study type: Interventional
• Intervention(s): strategy to intend to treat with myeloablative conditioning allogeneic hematopoietic stem cell transplantation

Outcome(s)

• Primary Outcome: Proportion of 3-year survival
• Secondary Outcome: Overall survival, 3-year survival of groups with or without suitable donor, 3-year survival with or without receiving allogeneic hematopoietic stem cell transplantation according to setting of the study, 3-year survival of all patients with or without allogeneic hematopoietic stem cell transplantation, adverse events, treatment related mortality

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) The proliferation of morphological abnormal lymphocytes and confirmation of T-cell with flowcytometry or immunostaining
2) Positive for serum anti HTLV-I antibody
3) Acute type, lymphoma type or chronic type with poor prognostic factor (Chronoic type with poor prognostic factor has at least one of the following data
i) BUN > 25 mg/dL
ii) LDH > 300 U/L
iii) Alb < 3.5 g/dL
4) Aged 20 to 65 years old
5) Preformance status 0-3
6) No prior chemotherapy or radiotherapy
7) No central nervus system involvement
8) Sufficient function of main organ
9) The will of receiving allogeneic hematopoietic stem cell transplantation
10) Written informed consent from patient

Exclude criteria

1) History of glaucoma
2) Uncontrollable diabetes mellitus or administration of insulin
3) Uncontrollable hypertension
4) Coronary artery disease requiring treatment, cardiomyopathy, cardiac failure, cardiac arrhythmia treated with antiarrhythmic drug
5) Active infection requiring systemic therapy
6) Fever over 38 degrees Celsius
7) HBs antigen positive
8) HCV antibody positive
9) HIV antibody positive
10) Acute hepatitis or liver cirrhosis
11) Interistitial pneumonitis, pulmonary fibrosis or pulmonary emphysema
12) Synchronous or metachronous malignancy
13) History of malignant lymphoma, myelodysplastic syndrome or leukemia
14) Women during pregnancy or milk breast-feeding
15) Psychosis or psychiatric symptoms
16) Emergency radiation for bulky mass
17) Systemic steroid treatment
18) History of interferon-alpha administration
19) History of allergic reaction by antibody drugs except for gamma globulin

Related Information

• Primary Sponsor: TSUKASAKI Kunihiro
• Secondary Sponsor: National Cancer Center Japan
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000004147