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COMPLETEDEARLY_PHASE1

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

NCT02846935•Yogen Saunthararajah

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically-proven T- or B-cell lymphoma
•Subjects must have received 1 or more prior therapies for this disease and have had stable disease or progressive disease based upon the criteria from the Revised Response Criteria for Malignant Lymphoma78, or intolerable toxicities precluding further therapy with a prior regimen
•Subjects must have measurable disease per Revised Response Criteria for Malignant Lymphoma78
•ECOG performance status 0 - 2
•Adequate organ function as defined by the following criteria:
•* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x laboratory upper limit of normal (ULN)
•* Total serum bilirubin ≤ 2.0 x ULN (except if Gilbert's disease)
•* Absolute neutrophil count (ANC) ≥ 1500/uL
•* Platelets ≥ 50,000/uL
•* Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
+4 more criteria

Exclusion Criteria

•Life expectancy ≤ 4 months in the judgment of the treating clinician
•Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with oral THU-Dec. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.
•Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because oral THU-Dec has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential, risk for adverse events in nursing infants secondary to treatment of the mother with oral THU-Dec, breastfeeding should be discontinued if the mother is treated with oral THU-Dec.
•Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
•Receiving other investigational agent

Locations (1)

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

April 25, 2017

Primary Completion Date

January 22, 2018

Completion Date

January 22, 2018

Last Updated

January 7, 2019

Enrollment

ACTUAL participants

Conditions

T-cell LymphomaAggressive B-cell LymphomaNon-Hodgkin's LymphomasIndolent B-cell Lymphoma

Interventions

Decitabine

DRUG

Tetrahydrouridine

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE3

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

NCT06561048

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell Lymphoma+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

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BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma