uPBSCT with PTCY for AT

Phase 2

Recruiting

• Conditions: adult T-cell leukemia/lymphoma

• Registration Number: JPRN-jRCTs031200375
• Lead Sponsor: Fukuda Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without grade III-IV acute GVHD at 100 days after transplantation

Secondary Outcome Measures

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