Loading clinical trials...

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

NCT00274651•Valerio Therapeutics

View on ClinicalTrials.gov

Summary

Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female with age \> or = 18 years.
•Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL).
•Must have failed at least one line of prior systemic therapy. No limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible.
•The presence of measurable disease (defined as \> or = 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT).
•Adequate bone marrow and hepatic function including the following:
•* Absolute neutrophil count \> or = 1,000 cells/mm3, platelets \> or = 40,000/mm3
•* Total bilirubin \< or = 1.5 x upper normal limit or \< or = 3 x upper normal limit if hepatic involvement
•* AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine aminotransferase) \< or = 2.5 x upper normal limit (\< or = 5 x upper normal limit if hepatic involvement)
•* Hemoglobin \> or = 9.0 g/dL.
•Serum potassium within normal range.
+3 more criteria

Exclusion Criteria

•Anti-cancer therapies within 4 weeks of first PXD101 administration should be excluded unless toxicity from prior anti-cancer therapy has resolved or returned to baseline and cancer disease status warrants.
•Any use of investigational drugs within 4 weeks prior to study registration.
•Major surgery within 4 weeks of study drug administration.
•Prior allogeneic bone marrow transplant.
•A diagnosis of adult T-cell lymphoma/leukemia (ATLL) or precursor T-lymphoblastic lymphoma.
•Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures. However, patients with progressing CTCL whose open skin lesions are frequently infected may not be excluded from this trial at the discretion of Investigators.
•Clinically significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, history of sustained ventricular tachycardia, history of ventricular fibrillation or Torsade de Pointes, bradycardia (HR\<50bpm) with or without a pacemaker, bifascicular block with a right bundle branch block and a left anterior block, ischemic or severe valvular heart disease, a myocardial infarction within 6 months or a left ventricular ejection fraction \< 40% (by echocardiogram \[ECHO\] or multigated acquisition scan \[MUGA\]) within 3 months of study enrolment.
•A marked baseline prolongation of QT/QTc ((corrected) QT) interval, e.g., repeated demonstration of a QTc interval \> 450 milliseconds (msec). Long QT Syndrome; the required use of concomitant medication on belinostat infusion days that may cause Torsade de Pointes.
•Renal insufficiency defined as a calculated creatinine clearance of \< 45 mL/min/1.73 m2.
•A history of allergic reactions attributed to compounds of similar chemical or biological composition to PXD101 and L-arginine.
+4 more criteria

Locations (15)

Leland Stanford Junior University

Stanford, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Kansas City Cancer Center

Lenexa, Kansas, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Boston University Medical Center

Boston, Massachusetts, United States

NYU Medical Center

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Hopitaux du Haut Leveque

Pessac, France

Hospital Purpan

Toulouse, France

Key Dates

Start Date

January 1, 2006

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

July 28, 2015

Enrollment

ACTUAL participants

Conditions

Cutaneous T-Cell LymphomaPeripheral T-Cell LymphomaNon-Hodgkin's Lymphoma

Interventions

belinostat

DRUG

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

View study

RECRUITINGPHASE1/PHASE2

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

NCT06909877

Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

View study

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: July 28, 2015Data 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.

View ClinicalTrials.gov Terms and Conditions

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Inclusion Criteria

Exclusion Criteria

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

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

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

Real-world Outcomes of Peripheral T-cell Lymphoma: A Multicenter Retrospective and Prospective Cohort Study

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma