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Single-arm, Phase 2 Study of ValemetostatTosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma
(VALENTINE-PTCL01)

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma
(VALENTINE-PTCL01)

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Not Recruiting

May. 31, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Participants >= 18 years of age or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
- ECOG PS of 0, 1, or 2
- Cohort 1 relapsed/refractory peripheral T-cell lymphoma (PTCL): Diagnosis should be confirmed by the local pathologist. Eligible subtypes include:
- Enteropathy-associated T-cell lymphoma
- Monomorphic epitheliotropic intestinal T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Primary cutaneous T-cell lymphoma
- Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
- PTCL, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Follicular T-cell lymphoma
- Nodal PTCL with T-follicular helper (TFH) phenotype
- Anaplastic large cell lymphoma, ALK positive
- Anaplastic large cell lymphoma, ALK negative
- Cohort 2 relapsed/refractory adult T-cell leukemia/lymphoma (ATL) acute, lymphoma, or unfavorable chronic type. Relapsed/refractory ATL should be confirmed by the local pathologist; local diagnosis will be used for eligibility determination. The positivity of anti-human T-cell leukemia virus type 1 (HTLV-1) antibody will be locally determined for eligibility.
- Must have at least one lesion which is measurable in 2 perpendicular dimensions on computed tomography (or magnetic resonance imaging) based on local radiological read:
- Documented refractory, relapsed, or progressive disease after at least 1 prior line of systemic therapy.
Refractory is defined as:
- Failure to achieve CR (or CRu for ATL) after first-line therapy; or
- Failure to reach at least PR after second-line therapy or beyond.
- Must have at least 1 prior line of systemic therapy for PTCL or ATL.
- Participants must be considered hematopoietic cell transplantation (HCT) ineligible during screening due to disease status (active disease), comorbidities, or other factors.
- In the PTCL cohort, participants with anaplastic large cell lymphoma (ALCL) must have prior brentuximab vedotin treatment.

- Diagnosis of mycosis fungoides, Sezary syndrome and primary cutaneous ALCL, and systemic dissemination of primary cutaneous ALCL
- Diagnosis of precursor T-cell leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia
- Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer.
- Presence of active central nervous system involvement of lymphoma
- History of autologous HCT within 60 days prior to the first dose of study drug
- History of allogeneic HCT within 90 days prior to the first dose of study drug
- Clinically significant graft-versus-host disease (GVHD) or GVHD requiring systemic immunosuppressive prophylaxis or treatment
- Inadequate washout period from prior lymphoma-directed therapy before enrollment, defined as follows:
- Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dose of study drug
- Had curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug
- Uncontrolled or significant cardiovascular disease
- History of treatment with other EZH inhibitors
- Current use of moderate or strong cytochrome P450 (CYP)3A inducers
- Systemic treatment with corticosteroids (>10 mg daily prednisone equivalents).
- Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients

Both

Relapsed/Refractory Peripheral T-Cell Lymphoma, Including Adult T-Cell Leukemia/Lymphoma

Oral administration of valemetostat tosylate at a dose of 200 mg once daily

Percentage of participants with Objective Response as assessed by Blinded Independent Central Review after administration of Valemetosate Tosylate monotherapy (Cohort 1)
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)

Plasma Concentrations of DS-3201a and CALZ-1809a, After Administration of Valemetosate Tosylate Monotherapy (All cohorts)
Duration of Response, Percentage of Participants With Complete Response, Duration of Complete Response, Percentage of Participants With Partial Response, Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetosate Tosylate Monotherapy (Cohort 1)

+81-99-275-5553

Feb. 08, 2021

Yes

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Information: - Study Protocol - Statistical Analysis Plan (SAP) - Informed Consent Form (ICF) Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

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