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Compares treatment options for PTCL
Official title Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
ClinicalTrials.gov ID: NCT04747236
What this study is testing
What is Azacytidine?
Azacytidine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ptcl.
Also referred to as Vidaza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Patients must have histologically...
- Patients are required to have no more than 3 lines of prior therapy (with cytoreductive therapy [ex ICE, DHAP, etc.] followed by autologous stem cell...
- Patients with anaplastic large cell lymphoma are required to have received brentuximab vedotin (Bv) prior to study enrollment.
- Measurable Disease as defined in Section 8.1.3.1.
- Age ≥18 years.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of patch/plaque stage mycosis fungoides
- Prior Therapy: Prior exposure to any hypomethylating agent or any histone deacetylase inhibitor (ex: romidepsin, chidamide, belinostat, or...
- Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs.
- No other concurrent investigational agents are allowed within 2 weeks of enrollment.
- Known central nervous system metastases, including lymphomatous meningitis
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Patients must have histologically confirmed relapsed or refractory peripheral T-cell lymphoma as defined by...
- Patients are required to have no more than 3 lines of prior therapy (with cytoreductive therapy [ex ICE, DHAP, etc.] followed by autologous stem cell transplant counting as one line of therapy). Patients are eligible if...
- Patients with anaplastic large cell lymphoma are required to have received brentuximab vedotin (Bv) prior to study enrollment.
- Measurable Disease as defined in Section 8.1.3.1.
- Age ≥18 years.
- ECOG performance status ≤2
- Patients must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC): ≥1000/mm3 (≥1000/dL); Platelets: \> 75,000/mm3; Serum Creatinine:\ 50 mL/min/for patients with creatinine levels...
- Negative urine or serum pregnancy test for females of childbearing potential
- All females of childbearing potential and male people must agree to use an effective method of contraception (see section 5.4 for more details)
- Be willing and able to provide written consent or assent for the trial.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of patch/plaque stage mycosis fungoides
- Prior Therapy: Prior exposure to any hypomethylating agent or any histone deacetylase inhibitor (ex: romidepsin, chidamide, belinostat, or vorinostat); exposure to chemotherapy or radiotherapy within 2 weeks prior to...
- Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs.
- No other concurrent investigational agents are allowed within 2 weeks of enrollment.
- Known central nervous system metastases, including lymphomatous meningitis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Nursing women
- Other active concurrent malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast (DCIS or LCIS). If there is a history of prior malignancy, the patient must be...
- Patients known to be Human Immunodeficiency Virus (HIV)-positive.
- Patients with active Hepatitis A, hepatitis B, or hepatitis C infection.
- Concomitant use of CYP3A4 inhibitors (see Section 13.3)
- History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would...
- Abnormal coagulation parameters (PT \>15 seconds, PTT\>40 seconds, and/or INR \>1.5) unless related to ongoing anticoagulation treatment required by the patient.
- Known or suspected hypersensitivity to azacitidine (or any excipients in the formulation) or mannitol.
- Any known cardiac abnormalities such as:
- Congenital long QT syndrome
- QTc interval ≥ 500 millisecond (using the Fridericia formula)
- Patients taking drugs leading to significant QT prolongation (See Section 13.2)
- Myocardial infarction within 6 months of C1D1. [people with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress...
- Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
- Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Section 13.4) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to...
- An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if...
- Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Section 13.5) and/or ejection fraction \<40% by MUGA scan or \<50% by echocardiogram and/or MRI;
- A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest;
- Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;
- Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion...
- Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- New Haven, Connecticut, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; New Haven, Connecticut, United States; New York, New York, United States; Durham, North Carolina, United States; Columbus, Ohio, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.