Clinical trial · Interventional
Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)
NCT01839097CI-TRIAL-00042570completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat | Drug | Belinostat | ALIAS |
| CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Finding Phase
- description
- This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose of Belinostat when administered in combination with CHOP. In Part A of the study, up to three sequential dose cohorts will enroll a maximum of 6 patients each. Enrollment will begin with the enrollment of patients into Cohort 3. On Day 1 of each 21-day treatment cycle, the study treatment will start with belinostat followed by CHOP regimen.
- interventionNames
- Drug: Belinostat
- Drug: CHOP
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- up to 5 days
- description
- To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or above * Life Expectancy \> 3 months * Histologically confirmed diagnosis of PTCL * Patients with transformed CTCL eligible for CHOP regimen * Measurable disease based on Cheson 2007 criteria * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 Exclusion Criteria: * Known active Hepatitis B/ Hepatitis C/ HIV infection * Known, uncontrolled CNS metastases or primary CNS lymphoma * Deep vein thrombosis diagnosed within 3 months * Ongoing treatment for pre-existing cardiovascular disease * Neuropathy Grade 3 or more * Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation * Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation * Prior therapy with HDAC inhibitors (except for CTCL) * Inadequate hematological, hepatic, or renal function
References
Publications (1)
- DERIVEDJohnston PB, Cashen AF, Nikolinakos PG, Beaven AW, Barta SK, Bhat G, Hasal SJ, De Vos S, Oki Y, Deng C, Foss FM. Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. Exp Hematol Oncol. 2021 Feb 18;10(1):15. doi: 10.1186/s40164-021-00203-8. PMID 33602316