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Anti-metabolites

Azacytidine + Romidepsin for Peripheral T-Cell Lymphoma (PTCL Trial)

Phase 2
Recruiting
Led By Enrica Marchi, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
Patients must have histologically confirmed relapsed or refractory peripheral T-cell lymphoma as defined by 2016 WHO criteria (Section 13.7), who have progressed following one line of prior systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of informed consent until 90 days after the last day of study treatment for all adverse events or anytime for serious adverse events considered related to the study intervention, through study completion, an average of 18 months.
Awards & highlights

PTCL Trial Summary

This trial will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL, in order to determine whether the combination treatment is safe and effective.

Who is the study for?
Adults (18+) with Peripheral T-Cell Lymphoma that's come back or hasn't responded to treatment can join this trial. They should have tried no more than three treatments before, and if they've had a stem cell transplant, it counts as one line of therapy. Participants need good organ function, manageable heart conditions, not be HIV-positive or pregnant, and agree to use contraception.Check my eligibility
What is being tested?
The study is testing if combining two drugs—oral azacytidine and romidepsin—is better for treating PTCL compared to the standard single-agent therapies chosen by the investigator (belinostat, pralatrexate or gemcitabine). Patients will be randomly assigned to receive either the combination treatment or one of the standard therapies.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems. There may also be liver issues indicated by abnormal tests results and potential heart rhythm problems.

PTCL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My T-cell lymphoma has returned or didn't respond to treatment after one therapy.
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I have anaplastic large cell lymphoma and have been treated with brentuximab vedotin.
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I can take care of myself but might not be able to do heavy physical work.

PTCL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of informed consent until 90 days after the last day of study treatment for all adverse events or anytime for serious adverse events considered related to the study intervention, through study completion, an average of 18 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of informed consent until 90 days after the last day of study treatment for all adverse events or anytime for serious adverse events considered related to the study intervention, through study completion, an average of 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
Complete response rate
Duration of response rate
Frequency of adverse events
+3 more

Side effects data

From 2018 Phase 2 trial • 16 Patients • NCT02196857
31%
Febrile Neutropenia
31%
Lung Infection
25%
Hypotnesion
25%
Diarrhea
25%
Fatigue
13%
Laryngeal Inflammation
13%
Nausea
13%
Urinary Tract Infection
13%
Pain
13%
Colitis
13%
Dyspnea
13%
Dyspena
6%
Hypercalcemia
6%
Vomiting
6%
Syncope
6%
Arthritis
6%
Watery eye
6%
Tremor
6%
Facial Pain/Dental
6%
Intracranial Hemorrhage
6%
Infection
6%
Cough
6%
Intestine Obstruction
6%
Fever
6%
Rash
6%
Laryngeal Hemorrhage
6%
Acute Heart Failure
6%
Acute Kidney failure
6%
Acute Respiratory Failure
6%
Cardiac Triponin Increase
6%
Cellulitis
6%
Dehydration
6%
Thrombocytopenia
6%
generalized edema
6%
Seizure
6%
Sepsis
6%
Skin Infection
6%
Stroke
6%
Dizziness
6%
Edema
6%
Hemorrhage
6%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacytidine + Sorafenib

PTCL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AZA and ROMIExperimental Treatment2 Interventions
Oral Azacytidine (AZA) (300 mg daily on days 1-14) plus Romidepsin (ROMI) (14 mg/m2 as an intravenous infusion over 4 hours +/- 30 minutes on days 8, 15 and 22 of a 35-day cycle.
Group II: Investigator's ChoiceActive Control4 Interventions
Investigator's choice to include: ROMI, 14 mg/m2 IV infusion on days 1, 8, and 15 of a 28 day cycle, belinostat,1000 mg/m2 IV infusion on days 1-5 every 21 days, pralatrexate, 30 mg/m2 IV push once weekly for 6 weeks of a 7-week treatment cycle, or gemcitabine, 1000 mg/m2 IV infusion on days 1, 8, and 15 of a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacytidine
2008
Completed Phase 2
~140
Romidepsin
2011
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,023 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,804 Total Patients Enrolled
Enrica Marchi, MDPrincipal Investigator - University of Virginia
University of Virginia Medical Center

Media Library

Azacytidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04747236 — Phase 2
Peripheral T-Cell Lymphoma Research Study Groups: AZA and ROMI, Investigator's Choice
Peripheral T-Cell Lymphoma Clinical Trial 2023: Azacytidine Highlights & Side Effects. Trial Name: NCT04747236 — Phase 2
Azacytidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747236 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Azacytidine been substantiated by the FDA?

"Azacytidine's safety has been partially validated in a series of Phase 2 trials. As such, it received an estimated score of two for its risk profile."

Answered by AI

Is it possible to participate in this experiment if one qualifies?

"As per the data hosted on clinicaltrials.gov, this medical study is actively seeking participants. The trial was initially posted on February 19th 2021 and last modified November 16th 2022."

Answered by AI

For what medical indications is Azacytidine commonly prescribed?

"Azacytidine is widely used to treat urinary bladder conditions, and can also improve Complete Blood Count (CBC), provide induction chemotherapy support, and combat Small cell lung cancer (SCLC)."

Answered by AI

How many healthcare facilities have undertaken this scientific experiment?

"The VA Long Beach Health Care System in California, University of Virginia in Charlottesville and Yale Cancer Center in Connecticut are just a few of the trial locations. In total, there are 4 sites taking part in this research project."

Answered by AI

How many individuals are participating in this trial's research?

"Celgene's medical trial requires 74 participants that meet the specified criteria to be conducted. It will take place across multiple sites, including VA Long Beach Health Care System located in Long Beach and University of Virginia in Charlottesville."

Answered by AI

Are there any other investigations that have explored the effectiveness of Azacytidine?

"Presently, 636 studies are being conducted on Azacytidine; 165 of them are currently in the third phase. While many trials for this treatment occur in Adelaide, South Australia, there is a total number of 30393 research sites undertaking investigations into it."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Enrica Marchi, MD 2021. "Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04747236.
~1 spots leftby Jun 2024
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