Adult T-cell leukemia-lymphoma (ATL)
Conditions
Interventions
None listed
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients registered in the aggressive ATL registry 2) Patients with relapsed or refractory ATL for whom therapeutic options have been adequately explained, and who are scheduled for initial administration of valemetostat 3) Patients aged 16 years or older 4) Written informed consent for participation in this study has been obtained from the patient. However, if the patient is between 16 and 18 years of age at the time of registration, written informed consent must be obtained both from the patient and from an adult guardian (or legally authorized representative)
Exclusion criteria
Exclusion criteria: 1) Patients with a history of valemetostat administration (including administration in clinical trials) prior to enrollment in this study 2) Patients with a history of allogeneic hematopoietic stem cell transplantation. However, patients scheduled for transplantation are eligible for enrollment. 3) Patients who plan or are expected to relocate or receive follow-up care outside the study institution within two weeks after valemetostat administration 4) Patients who are pregnant or potentially pregnant women, or women who are breastfeeding 5) Patients who are considered to be unsuitable for enrollment by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in H3K27me3-Flow methylated histone levels pre- and post-valemetostat administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival 1-year overall survival 1-year event-free survival Overall response rate Complete response rate Adverse events Alterations in whole-exome sequencing and gene expression analysis pre- and post- valemetostat administration | — |
Countries
Japan
Contacts
Public ContactJunya Makiyama
Sasebo City General Hospital Department of Hematology
Outcome results
None listed