BridgeMD
Tests treatment safety and results for Peripheral T Cell Lymphoma
Official title To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
ClinicalTrials.gov ID: NCT06072131
What this study is testing
What is Belinostat Injection?
Belinostat Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for peripheral t cell lymphoma.
Also referred to as Beleodaq®.
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
- Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study. Part 2 (Efficacy and Safety): This is a 3 Arm study.
- Phase 3: a large, late-stage study
- 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
- Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat...
- Pathology subtype:
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not...
You likely can't join if
- A patient will not be eligible for inclusion if ANY of the criteria listed below apply:
- Patients with a diagnosis of:
- Precursor T-cell lymphoma or leukemia
- Adult T-cell lymphoma/leukemia
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
See the full eligibility criteria
- Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each...
- Pathology subtype:
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is...
- Follicular T-cell lymphoma
- Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma
- CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation.
- Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3)
- Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2
- For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:
- Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement
- Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement
- Total bilirubin ≤1.5 mg/dL
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented...
- Calculated creatinine clearance of ≥ 60 mL/min
- Part 2 (how well it works and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the...
- Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement
- Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement
- Total bilirubin ≤1.5 mg/dL
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if...
- Calculated creatinine clearance of ≥ 60 mL/min
- UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation.
- Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements
- Patient (male or female) is at least 18 years of age at the time of informed consent
- Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment.
- Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months...
- A patient will not be eligible for inclusion if ANY of the criteria listed below apply:
- Patients with a diagnosis of:
- Precursor T-cell lymphoma or leukemia
- Adult T-cell lymphoma/leukemia
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Primary cutaneous type ALCL
- Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)
- ALCL if they can be treated with Brentuximab Vedotin (BV)
- Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat
- Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the...
- Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy
- Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (i.e. demonstration of a QTc interval \>450 msec); long QT syndrome; myocardial infarction within 6 months prior to...
- Patient with uncontrolled hypertension
- Patients status on the following:
- Has a known HIV-positive diagnosis with uncontrolled and detectable viral load
- Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease
- Patient with central nervous system metastasis
- Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment
- Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study
- Patient with a known history of drug or alcohol abuse
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Clovis, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Pembroke Pines, Florida, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- Harlingen, Texas, United States
- Houston, Texas, United States
- Temple, Texas, United States
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Göttingen, Germany
- Halle, Germany
- Debrecen, Nagyerdei Krt. 98, Hungary
- Nyíregyháza, Szent Istvan Utca, Hungary
- Budapest, Hungary
- Eger, Hungary
- Szeged, Hungary
- Tricase, Apulia, Italy
+ 45 more site(s).
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 Clovis, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; Pembroke Pines, Florida, United States; Louisville, Kentucky, United States; Detroit, Michigan, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.