Clinical Trials List
Protocol NumberSPI-BEL-301
NCT Number(ClinicalTrials.gov Identfier)NCT06072131
Active
2024-02-28 - 2030-03-31
Phase III
Recruiting6
A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
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Trial Applicant
Syneos Health
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/22
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ta-Chih Liu 無
- 吳敬炫 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊博雅 Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- HUI-WEN LIU Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 高小雯 無
- 林潔 Division of Nuclear Medicine
- 陳建誠 Division of Radiology
- HSUAN JEN SHIH 無
- Ming-Chung Kao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ya-Ting Hsu
Co-Principal Investigator
- Tsai-Yun Chen Division of General Internal Medicine
- 傅蓓安 Division of General Internal Medicine
- Chih-Chieh Yen Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Peripheral T Cell Lymphoma
Objectives
Part 1 (Dose Exploration):
Primary Objective
• To identify an optimal dose level for belinostat and pralatrexate in the two dose levels of the multiple chemotherapy regimen in Part 2 of the trial, based on safety and overall response rate (ORR) at month 3.
Part 2 (Efficacy and Safety):
Primary Objectives
• In newly diagnosed peripheral T-cell lymphoma (PTCL) patients who have received up to 6 cycles of therapy, compare the progression-free survival (PFS) of belinostat plus CHOP (Bel-CHOP) or pralatrexate plus COP (Fol-COP) compared to CHOP monotherapy.
Secondary Objectives
• In newly diagnosed PTCL patients, compare the overall survival (OS) of Bel-CHOP or Fol-COP therapy compared to CHOP monotherapy.
• In newly diagnosed PTCL patients, compare the objective response rate of Bel-CHOP or Fol-COP therapy compared to CHOP monotherapy.
• Treatment adherence
Exploratory Objectives
• Dose intensity
• In newly diagnosed PTCL patients, compare the duration of response of Bel-CHOP or Fol-COP therapy compared to CHOP monotherapy.
• In newly diagnosed PTCL patients, compare... The proportion of patients receiving hematopoietic stem cell transplantation with Bel-CHOP or Fol-COP therapy compared to CHOP therapy alone.
Safety Targets: Evaluate the safety profile of Bel-CHOP or Fol-COP therapy compared to CHOP therapy alone in newly diagnosed PTCL patients.
Test Drug
Frozen crystal powder for injection
Injection
Injection
Active Ingredient
Belinostat
Pralatrexate
Pralatrexate
Dosage Form
048
270
270
Dosage
500 mg
40 mg/2ml
40 mg/2ml
Endpoints
• The primary endpoint of this experiment will be PFS.
Inclution Criteria
Inclusion 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 patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:
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 contraindicated to receive BV.
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 hepatic involvement with lymphoma)
Calculated creatinine clearance of ≥ 60 mL/min
Part 2 (Efficacy 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 following restrictions:
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 documented hepatic involvement with lymphoma)
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 since last menses) or are surgically sterilized do not require this test.
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 patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:
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 contraindicated to receive BV.
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 hepatic involvement with lymphoma)
Calculated creatinine clearance of ≥ 60 mL/min
Part 2 (Efficacy 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 following restrictions:
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 documented hepatic involvement with lymphoma)
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 since last menses) or are surgically sterilized do not require this test.
Exclusion Criteria
Exclusion Criteria:
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 cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years
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 starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes
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
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 cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years
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 starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes
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 Estimated Number of Participants
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Taiwan
33 participants
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Global
504 participants
