Skip to content

feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study)

feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study) - ZAAT study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007569
Enrollment
21
Registered
2012-03-27
Start date
2012-03-01
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

Treatment of zoledronic acid

Sponsors

Saga University, Faculty of Medicine, Devision of Hematology and Oncology
Lead Sponsor
Karatsu red-cross hospiral
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Confirmation of T-cell with hematological or pathological examination b) positive for anti HTLV-1 antibody c) Acute type, lymphoma type or transformed to acute or lymphoma type from chronic or smoldering type d) Aged 15 to 75 years old e) perfomance status 0-3, PS 4 caused by hypercalcemia is eligible f) No prior chemotherapy or radiotherapy for ATL, except for steroid g) No central nervus system involvement at diagnosis h) Sufficient function of main organ i) No the need for invasive dental treatment j) Written informed consent from a patient. If consciousness disturbance caused by hypercalcemia, it allowed to the acceptance of family

Exclusion criteria

Exclusion criteria: a)History of glaucome b) Uncontrollable diabetes mellitus or administration of insulin c) Uncontrollable hypertension d) Poor cardiac function e) Active infection requiring systemic therapy f) acute hepatitis, chronic hepatitis, liver cirrhosis g) Synchronous or metachronous maliganacy h) Psychological problem i) active dental disease indicating invasive dental treatment j) Systemic steroid treatment k) History of adminisration of intravenous bisphophonate

Design outcomes

Primary

MeasureTime frame
progression free survival in one year

Secondary

MeasureTime frame
progression free hypercalcemia, overall suvival in one year, feasibility for scheduled zoledronic acid

Countries

Japan

Contacts

Public ContactNoriyasu Fukushima

Saga University, Faculty of Medicine Hematology and Oncology

fukushin@cc.saga-u.ac.jp

Outcome results

None listed

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