VALENTINE-PTCL01
Research type
Research Study
Full title
Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma
IRAS ID
1003801
Contact name
Naushad Islam
Contact email
Sponsor organisation
DAIICHI SANKYO, INC.
Eudract number
2020-004954-31
Clinicaltrials.gov Identifier
Research summary
Peripheral T-cell lymphoma (PTCL) is a group of rare lymphoid malignancies (cancers originating from immune system cells). ATL is a subtype of PTCL.
Patients with PTCL have a poor prognosis, with the 5-year overall survival (OS) and 5-year progression-free survival (PFS) being 34.1% and 25.7%, respectively.
For patients with R/R (relapsed/refractory, meaning worsening/unresponsive) PTCL, the therapeutic options are currently limited. First-line standard of care therapy for most PTCL subtypes has not changed for decades. CHOP (chemotherapy)-based regimens, the current standard treatment for PTCL patients, were initially adopted from the regimen for B-cell Non-Hodgkin Lymphoma (B-NHL) without a strong scientific rationale specific to PTCL. No drug is approved for R/R PTCL in the European Union. Patients who are able to achieve a good response can undergo bone marrow transplant for potential cure, but this is limited due to lack of adequate donors and patients’ other conditions. Thus, there remains a compelling unmet need for improved therapies for patients with R/R PTCL and ATL.
The main purpose of this study is to gather information about an investigational drug called valemetostat tosylate, that may help to treat patients with R/R PTCL or ATL.
Valemetostat tosylate is designed to inhibit (block) two enzymes, EZH1 and EZH2. These enzymes are produced in high amounts in cancer cells which may be related to disease progression and worsening even when patients are on standard treatments. This study will investigate whether blocking these enzymes with the study drug helps to prevent the process responsible for cancer cells growing and multiplying, leading to the worsening of disease.
There will be approximately 176 subjects enrolled in this study at about 70 centres in multiple countries around the world. The study is expected to last for approximately 56 months. This study is being sponsored by Daiichi Sankyo, Inc.REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0256
Date of REC Opinion
14 Oct 2021
REC opinion
Further Information Favourable Opinion