Clinical Trials List
Protocol NumberSPI-BEL-301
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
Acrotech Biopharma Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- Tsai-Yun Chen Division of General Internal Medicine
- 傅蓓安 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳敬炫 無
- Ta-Chih Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HSUAN JEN SHIH 無
- Ming-Chung Kao 無
- 林潔 Division of Nuclear Medicine
- 陳建誠 Division of Radiology
- 高小雯 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
TSU-YI CHAO
Co-Principal Investigator
- Yao-Yu Hsieh Division of Hematology & Oncology
- HUI-WEN LIU
- Wei-Hong Cheng
- 莊博雅
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Peripheral T-Cell Lymphoma
Objectives
• To identify one of two dose-levels, each for belinostat and pralatrexate, that is optimal in polychemotherapy
for the part 2 study based on safety and ORR at 3 months.
Test Drug
injection
Active Ingredient
Belinostat
Pralatrexate
Pralatrexate
Dosage Form
048
270
270
Dosage
MG
ml
ml
Endpoints
The primary endpoint for this study will be PFS.
Inclution Criteria
1. Patients with newly diagnosed, untreated, histologically confirmed peripheral T-cell lymphoma, based on local pathological examination, are eligible for Belinostat, Pralatrexate, and CHOP. Each patient must provide pathological data at the trial center prior to enrollment for verification by the trial commissioner (or designated personnel). The following subtypes may be included according to the updated World Health Organization (WHO) classification. This information should be provided to determine eligibility:
a. Pathological subtypes:
o Peripheral T-cell lymphoma, unless otherwise specified
o Angioimmunoblastic T-cell lymphoma
o Anaplastic lymphoma kinase (ALK) negative anaplastic large cell lymphoma (ALCL) is eligible only if Brentuximab Vedotin (BV) is not commercially approved, not available in the patient's country, or if the patient is prohibited from receiving BV.
o Follicular T-cell lymphoma
o Others: Extranodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous pancreatitis-like T-cell lymphoma
b. CD30 manifestation and follicular helper T-cell (TFH) phenotype status must be documented.
2. As assessed by the local trial administrator according to the 2017 Response to Lymphoma (RECIL) criteria, the patient has at least one measurable disease site (Appendix 3).
3. The patient's East Coast Cancer Clinical Research Partnership (ECOG) performance status is ≤2.
4. For Part 1 (Dose Exploration) – the patient has adequate hematological, hepatic, and renal function, defined as follows:
a. Absolute neutrophil count ≥1.5 × 10⁹/L or ≥1.0 × 10⁹/L if there is evidence of bone marrow involvement.
b. Platelet count ≥100 × 10⁹/L or ≥75 × 10⁹/L if there is evidence of bone marrow involvement.
c. Total bilirubin ≤1.5 mg/dL
d. Aspartate transaminase (AST) / serum glutamate-oxalate-acetate transaminase (SGOT), alanine transaminase (ALT)/Serum glutamate-pyruvate transaminase (SGPT) ≤3x Upper Limit of Normal (ULN); AST/ALT ≤5×ULN, if there is a record of lymphoma involvement of the liver.
e. Calculated serum creatinine clearance ≥ 60 mL/min
5. Part 2 (Efficacy and Safety) – Disease-related developmental disorders, hepatic or renal impairments may be included if administration to any treatment group is recommended according to the package insert, subject to the following limitations:
a. Absolute neutrophil count ≥1.5×10⁹/L, or ≥1.0 × 10⁹/L if there is evidence of bone marrow involvement.
b. Platelet count ≥100×10⁹/L, or ≥75×10⁹/L if there is evidence of bone marrow involvement.
c. Total bilirubin ≤1.5 mg/dL
d. Aspartate transaminase (AST)/Serum glutamate-oxalate transaminase (SGOT), Alanine transaminase (ALT)/serum glutamate-pyruvate transaminase (SGPT) ≤3x Upper Limit of Normal (ULN); AST/ALT ≤5×ULN, if there is a record of lymphoma invading the liver.
e. Calculated serum creatinine clearance ≥ 60 mL/min
6. The characteristics of the UGT1A1 genotype have been analyzed (if abnormal, please refer to Belinostat dose adjustment), and documentation must be available.
7. The patient must be willing and able to provide written subject consent, and must be able to adhere to the medication and appointment schedule and meet all trial requirements.
8. The patient (male or female) must be at least 18 years old when signing the subject consent form.
9. From the start of the trial until at least 6 months after the last dose of trial treatment, the patient must be willing to use two methods of contraception, one of which must be a barrier method.
10. Women of childbearing potential must have a negative urine pregnancy test result within 4 weeks prior to the first day of trial treatment. Women who have stopped menstruating for at least one year (defined as more than 12 months since their last menstrual period) or who have undergone surgical sterilization do not need to undergo this test.
a. Pathological subtypes:
o Peripheral T-cell lymphoma, unless otherwise specified
o Angioimmunoblastic T-cell lymphoma
o Anaplastic lymphoma kinase (ALK) negative anaplastic large cell lymphoma (ALCL) is eligible only if Brentuximab Vedotin (BV) is not commercially approved, not available in the patient's country, or if the patient is prohibited from receiving BV.
o Follicular T-cell lymphoma
o Others: Extranodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous pancreatitis-like T-cell lymphoma
b. CD30 manifestation and follicular helper T-cell (TFH) phenotype status must be documented.
2. As assessed by the local trial administrator according to the 2017 Response to Lymphoma (RECIL) criteria, the patient has at least one measurable disease site (Appendix 3).
3. The patient's East Coast Cancer Clinical Research Partnership (ECOG) performance status is ≤2.
4. For Part 1 (Dose Exploration) – the patient has adequate hematological, hepatic, and renal function, defined as follows:
a. Absolute neutrophil count ≥1.5 × 10⁹/L or ≥1.0 × 10⁹/L if there is evidence of bone marrow involvement.
b. Platelet count ≥100 × 10⁹/L or ≥75 × 10⁹/L if there is evidence of bone marrow involvement.
c. Total bilirubin ≤1.5 mg/dL
d. Aspartate transaminase (AST) / serum glutamate-oxalate-acetate transaminase (SGOT), alanine transaminase (ALT)/Serum glutamate-pyruvate transaminase (SGPT) ≤3x Upper Limit of Normal (ULN); AST/ALT ≤5×ULN, if there is a record of lymphoma involvement of the liver.
e. Calculated serum creatinine clearance ≥ 60 mL/min
5. Part 2 (Efficacy and Safety) – Disease-related developmental disorders, hepatic or renal impairments may be included if administration to any treatment group is recommended according to the package insert, subject to the following limitations:
a. Absolute neutrophil count ≥1.5×10⁹/L, or ≥1.0 × 10⁹/L if there is evidence of bone marrow involvement.
b. Platelet count ≥100×10⁹/L, or ≥75×10⁹/L if there is evidence of bone marrow involvement.
c. Total bilirubin ≤1.5 mg/dL
d. Aspartate transaminase (AST)/Serum glutamate-oxalate transaminase (SGOT), Alanine transaminase (ALT)/serum glutamate-pyruvate transaminase (SGPT) ≤3x Upper Limit of Normal (ULN); AST/ALT ≤5×ULN, if there is a record of lymphoma invading the liver.
e. Calculated serum creatinine clearance ≥ 60 mL/min
6. The characteristics of the UGT1A1 genotype have been analyzed (if abnormal, please refer to Belinostat dose adjustment), and documentation must be available.
7. The patient must be willing and able to provide written subject consent, and must be able to adhere to the medication and appointment schedule and meet all trial requirements.
8. The patient (male or female) must be at least 18 years old when signing the subject consent form.
9. From the start of the trial until at least 6 months after the last dose of trial treatment, the patient must be willing to use two methods of contraception, one of which must be a barrier method.
10. Women of childbearing potential must have a negative urine pregnancy test result within 4 weeks prior to the first day of trial treatment. Women who have stopped menstruating for at least one year (defined as more than 12 months since their last menstrual period) or who have undergone surgical sterilization do not need to undergo this test.
Exclusion Criteria
1. Patients diagnosed with:
a. Precursor T-cell lymphoma or leukemia
b. Adult T-cell lymphoma/leukemia
c. T-cell prolymphocytic leukemia
d. T-cell large granular lymphocytic leukemia
e. Primary cutaneous ALCL
f. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)
g. ALCL, if Brentuximab Vedotin (BV) is available for treatment
2. Patients taking potent UGT1A1 inhibitors must discontinue their medication one week prior to randomization; if belinostat is not included in the treatment regimen, it may be resumed.
3. Patients with active concomitant malignancies/life-threatening diseases, excluding those who have received treatment resulting in complete cancer remission and currently do not have active or recurrent clinical, radiological, or laboratory evidence of non-melanoma skin tumors and cervical cancer in situ. 4. Patients with a history of malignancy/life-threatening disease must be disease-free for at least 5 years.
5. Previous treatment with histrin deacetase (HDAC) inhibitors or pralatrexate.
6. Any known cardiac abnormalities, such as prolonged baseline QT/corrected QT (QTc) interval (i.e., QTc interval >450 msec); QT prolongation syndrome; myocardial infarction within 6 months prior to start the trial; history of major cardiovascular disease; need for concomitant medications that may cause torsades de pointes.
7. Patients with poorly controlled hypertension.
8. Patients with the following conditions:
a) Known HIV-positive diagnosis with uncontrolled and measurable viral load.
b) Diagnosed with hepatitis B virus or hepatitis C virus. 8. Patients with hepatitis B virus type 1 or higher and with uncontrolled and measurable viral load or immunological evidence of chronic active disease.
9. Patients with central nervous system metastases.
10. Patients with poorly controlled active infections, underlying medical conditions, abnormal laboratory test results, or other serious illnesses that may impair their ability to receive treatment as per the trial protocol.
11. Patients who have used any investigational drug, biologic, or device within 28 days prior to the trial treatment, or who plan to use any of these drugs, biologics, or devices during the trial.
12. Patients with a known history of drug or alcohol abuse.
13. Pregnant or lactating women.
a. Precursor T-cell lymphoma or leukemia
b. Adult T-cell lymphoma/leukemia
c. T-cell prolymphocytic leukemia
d. T-cell large granular lymphocytic leukemia
e. Primary cutaneous ALCL
f. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)
g. ALCL, if Brentuximab Vedotin (BV) is available for treatment
2. Patients taking potent UGT1A1 inhibitors must discontinue their medication one week prior to randomization; if belinostat is not included in the treatment regimen, it may be resumed.
3. Patients with active concomitant malignancies/life-threatening diseases, excluding those who have received treatment resulting in complete cancer remission and currently do not have active or recurrent clinical, radiological, or laboratory evidence of non-melanoma skin tumors and cervical cancer in situ. 4. Patients with a history of malignancy/life-threatening disease must be disease-free for at least 5 years.
5. Previous treatment with histrin deacetase (HDAC) inhibitors or pralatrexate.
6. Any known cardiac abnormalities, such as prolonged baseline QT/corrected QT (QTc) interval (i.e., QTc interval >450 msec); QT prolongation syndrome; myocardial infarction within 6 months prior to start the trial; history of major cardiovascular disease; need for concomitant medications that may cause torsades de pointes.
7. Patients with poorly controlled hypertension.
8. Patients with the following conditions:
a) Known HIV-positive diagnosis with uncontrolled and measurable viral load.
b) Diagnosed with hepatitis B virus or hepatitis C virus. 8. Patients with hepatitis B virus type 1 or higher and with uncontrolled and measurable viral load or immunological evidence of chronic active disease.
9. Patients with central nervous system metastases.
10. Patients with poorly controlled active infections, underlying medical conditions, abnormal laboratory test results, or other serious illnesses that may impair their ability to receive treatment as per the trial protocol.
11. Patients who have used any investigational drug, biologic, or device within 28 days prior to the trial treatment, or who plan to use any of these drugs, biologics, or devices during the trial.
12. Patients with a known history of drug or alcohol abuse.
13. Pregnant or lactating women.
The Estimated Number of Participants
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Taiwan
33 participants
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Global
504 participants
