NCT02846935

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Yogen Saunthararajah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how well the study drug works and safety of oral decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is being given at a lower dose than used for its approved use. It is also being given with another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to decitabine.

Detailed description

Primary objective: To determine the objective response rate to oral THU-Dec in patients with 3 separate biologic subsets of refractory/relapsed lymphoid malignancies: 1. T-cell lymphoma, 2. Aggressive B cell lymphoma, 3. indolent B-cell lymphoma . Secondary objectives: (i) To evaluate the toxicity of oral THU-Dec in these patients; (ii) To evaluate hypotheses regarding mechanisms of resistance and predictive biomarkers.

Conditions

• T-cell Lymphoma
• Aggressive B-cell Lymphoma
• Non-Hodgkin's Lymphomas
• Indolent B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Decitabine	2-4 capsules depending on the weight of participant. Dec capsules are ingested \~60 minutes after THU capsules.
DRUG	Tetrahydrouridine	2-4 capsules depending on the weight of participant. Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days.

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2016-07-27
• Last updated: 2019-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study