Clinical trial · Interventional
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)
A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With Peripheral T-Cell Lymphoma (PTCL)
NCT02594267CI-TRIAL-00052910completedPhase 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 purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).
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 (PTCL) | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pralatrexate Injection | Drug | Pralatrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Finding, Cohort 1
- description
- Dose finding Phase Intervention: Folotyn (Pralatrexate Injection) CHOP: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone The first cohort will begin with three patients with dose A of pralatrexate plus CHOP at full dose. The second cohort will begin with three patients with dose B of pralatrexate plus CHOP at full dose. The third cohort will begin with three patients with dose C of pralatrexate plus CHOP at full dose. The fourth cohort will begin with three patients with dose D of pralatrexate plus CHOP at full dose. The fifth cohort will begin with three patients with dose E of pralatrexate plus CHOP at full dose. Part 2: Dose Expansion, Additional ten patients will be enrolled at the MTD or MAD (if the MTD is not reached) plus CHOP at full dose in this part of the study. Blood samples for PK analysis of pralatrexate will be collected at various intervals pre and post pralatrexate injection during cycle 1, Dose 1.
- interventionNames
- Drug: Pralatrexate Injection
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 126 Days
- description
- To evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or above 2. Adequate hematologic, hepatic, and renal function 3. Histologically confirmed, new diagnosis of PTCL 4. Eligible for CHOP regimen 5. Measurable disease based on Cheson 2007 criteria 6. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 7. Willing to perform at least two methods of contraception 8. Negative pregnancy test of females with childbearing potential. Exclusion Criteria: 1. Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years. 2. Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification. 3. Uncontrolled hypertension 4. Central nervous system (CNS) metastases . 5. Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment 6. Major surgery within 30 days prior to enrollment. 7. Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment. 8. Previous exposure to pralatrexate. 9. Pregnant or breastfeeding.
References
Publications (1)
- DERIVEDIyer SP, Johnston PB, Barta SK. Pralatrexate injection combined with CHOP for treatment of PTCL: results from the Fol-CHOP dose-finding phase 1 trial. Blood Adv. 2024 Jan 23;8(2):353-364. doi: 10.1182/bloodadvances.2023011095. PMID 38029357