Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)

Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT) - Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004147

Enrollment

110

Registered

2010-09-02

Start date

2010-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult T-cell leukemia-lymphoma

Interventions

strategy to intend to treat with allogeneic hematopoietic stem cell transplantation including both myeloablative and reduced intensity conditioning.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The proliferation of morphological abnormal lymphocytes and confirmation of T-cell with flowcytometry or immunostaining 2) Positive for ant HTLV-1 antibody 3) Acute type, lymphoma type or chronic type with poor prognostic factor (at least one of elevated level of BUN, elevated level of LDH and lower level of Alb) 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

Exclusion criteria

Exclusion criteria: 1) History of glaucome 2) Uncontrollable diabetes mellitus or administration of insulin 3) Uncontrollable hypertension 4) Poor cardiac function 5) Active infection requiring systemic therapy 6) Fever over 38 degrees centigrade 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 or leukemia 14) Women during pregnancy or milk breast-feeding 15) Psychological problem 16) 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

Design outcomes

Primary

Measure	Time frame
Proportion of 3-year survival	—

Secondary

Measure	Time frame
Overall survival, 3-year survival of subgroups, adverse events, treatment related mortality	—

Countries

Japan

Contacts

Public ContactTakuya Fukushima

JCOG0907 Coordinating Office Faculty of Medicine School of Health Sciences, University of the Ryukyus

JCOG_sir@ml.jcog.jp098-895-1276

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026