uPBSCT with PTCY for ATL

JRCT ID: jRCTs031200375

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: adult T-cell leukemia/lymphoma
• Date of first enrollment: 12/07/2021
• Target sample size: 24
• Study type: Interventional

Intervention(s)

(1) Unrelated peripheral blood stem cell transplantation
(2) GVHD prophylaxis with post-transplant cyclophosphamide(PTCY)
GVHD prophylaxis consists of tacrolimus starting at 0.02-0.03 mg/kg/day on day +5, PTCY(50 mg/kg/day on days +3 and +4), and mycophenolate mofetil 15 mg/kg BID starting on day +5.

Outcome(s)

• Primary Outcome: Survival without grade III-IV acute GVHD at 100 days after transplantation

Secondary Outcome

(1) Incidence and severity of acute and chronic GVHD at 100 days, and 1 year
(2) Non-relapse mortality at 100 days, and 1 year
(3) Incidence of relapse or progression at 100 days, and 1 year
(4) Overall survival and progression-free survival at 100 days, and 1 year
(5) Proportion of patients who discontinued immunosuppressive agents at 1 year
(6) Grade 3-4 toxicity within 100 days
(7) Incidence of infectious disease at 100 days, and 1 year
(8) Incidence of primary or secondary graft failure
(9) Time to hematological recovery
(10) Immune reconstitution

Key inclusion & exclusion criteria

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

Include criteria

1) Adult T-cell leukemia/lymphoma, acute or lymphoma type
2) Patients who have an HLA 6-8/8 matched unrelated peripheral blood stem cell donor
3) Age: 20-65 years old
4) ECOG performance status: 0 or 1
5) Disease status: CR, PR, or, SD
6) Written informed consent from the patient
7) Patients who are expected to survive for at least 3 months

Exclude criteria

1) Severe organ dysfunction in the heart, lung, kidney, or liver
2) Uncontrollable ATL lesion in central nervous system
3) Uncontrollable diabetes mellitus
4) Uncontrollable hypertension
5) Coronary artery disease requiring treatment, cardiomyopathy, cardiac failure, or arrhythmia requiring medication
6) Acute hepatitis, chronic active hepatitis, or liver cirrhosis
7) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest X-ray.
8) Infectious disease requiring systemic therapy
9) Simultaneous or metachronous (within 5 years) double cancers, except for carcinoma in situ resected by local therapy
10) History of lymphoma, myelodysplastic syndrome, or leukemia
11) History of anti-CCR4 antibody administration
12) Prior hematopoietic stem cell transplantation
13) High titer of anti-donor specific HLA antibody
14) Positive HIV antibody
15) Women during pregnancy or breastfeeding
16) Psychological disorder
17) Patients who are not eligible for this study at the discretion of the physician

Related Information

• Primary Sponsor: Fukuda Takahiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development