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

NCT02846935 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-01-07

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Yogen Saunthararajah

    lead OTHER

Principal Investigators

  • Brian Hill, MD, PhD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2018-01-22
Completion
2018-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02846935 on ClinicalTrials.gov