Phase Ib/II Study of the Combination of Tucidinostat and Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

JRCT ID: jRCT2041210129

Registered date:19/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: B-cell Non-Hodgkin's Lymphoma
• Date of first enrollment: 23/05/2022
• Target sample size: 71
• Study type: Interventional
• Intervention(s): Patients will receive tucidinostat at 40 mg QD twice weekly with a 3 to 4 day interval between doses and rituximab at 375 mg/m^2 on Day 1 of each Cycle in 21 day treatment cycles

Outcome(s)

• Primary Outcome: ORR at 6 to 8 weeks after the last dose of rituximab

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Part A: Patients with diagnosed B-NHL, Part B: Patients with diagnosed DLBCL
2) Patients who have relapsed or refractory following at least one systemic therapy
3) Patients who have had response to a previous treatment regimen that included anti CD20 therapy at least once
4) Patients who have normal systemic organ function

Exclude criteria

1) Patients with known double hit/triple hit lymphoma
2) Patients with bulky disease
3) Patients with a history or findings of cardiac disorders
4) Patients with gastrointestinal disorders or dysphagia which could affect oral medicine administration and absorption
5) Patients with a history of clinically significant pulmonary disorders (including interstitial lung disease, pneumonitis, obstructive pulmonary disease, and bronchospasm)
6) Patients with a history of or complications of other malignancies that have not been in remission for at least the last 5 years (except some cases)
7) Patients who are deemed by the principal investigator or sub-investigator to be unsuitable for participation in the study due to significant clinical findings, abnormal laboratory results, psychiatric disorders, or other conditions that could affect the results of the study

Related Information

• Primary Sponsor: Hatake Kiyohiko