Description:
This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat
tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell
leukemia/lymphoma (r/r ATL).
Title
- Brief Title: Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
- Official Title: A Phase 2, Multicenter, Open-label, Single-arm Study of Valemetostat Tosylate (DS-3201b) in Patients With Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
DS3201-A-J201
- SECONDARY ID:
194964
- NCT ID:
NCT04102150
Conditions
- Adult T-cell Leukemia/Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Valemetostat Tosylate | DS-3201b | DS-3201b |
Purpose
This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat
tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell
leukemia/lymphoma (r/r ATL).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| DS-3201b | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have
history of treatment with mogamulizumab or are mogamulizumab intolerant,
contraindication after treatment with at least 1 medication regimen
- Aged ≥20 years or older at the time of signing the informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- At least 1 evaluable lesion
- Participants who have defined laboratory criteria
- Life expectancy ≥ 3 months
Exclusion Criteria:
- A presence of central nervous system involvement at the time of screening tests
- Have poorly controlled complication (eg. chronic congestive heart failure, unstable
angina
- ≥ Grade 3 neuropathy
- QT interval corrected using Fridericia's method (QTcF) >470 ms
- Has an uncontrolled infection
- Participants who use corticosteroids over 10 mg/day
- Receipt of allogeneic hematopoietic stem cell transplantation
- History of, or concurrent, malignant tumors
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall response rate (ORR) assessed by central evaluation organization |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | The percentage of participants who were assessed for best overall response, who achieved complete remission (CR), complete remission, unconfirmed (CRu) or partial remission (PR) by central evaluation organization. |
Secondary Outcome Measures
| Measure: | Overall response rate (ORR) assessed by investigator |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator. |
| Measure: | Best response per tumor lesions |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions. |
| Measure: | Complete remission rate (CR rate) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | The percentage of participants who were assessed for best overall response, who achieved CR or CRu. |
| Measure: | Tumor control rate (TCR) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD). |
| Measure: | Time to response (TTR) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR |
| Measure: | Duration of response (DOR) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death. |
| Measure: | Progression-free survival (PFS) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | Period from the first day of DS-3201b dose to the day of RD/PD or death. |
| Measure: | Overall survival (OS) |
| Time Frame: | Through the end of the study (within approximately 5 years) |
| Safety Issue: | |
| Description: | Period from the first day of DS-3201b dose to death. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Last Updated
December 22, 2020
