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)
The goal of this clinical research study is to find the highest tolerable dose of pralatrexate (Folotyn) that can be given in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with PTCL.
Disease Group: Lymphoma
Treatment Agent: Cyclophosphamide,Doxorubicin,Pralatrexate,Prednisone,Vincristine
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Spectrum Pharmaceuticals, Inc., Allos Therapeutics, Inc.,
Primary Objective: 1) To evaluate the Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL). 2)To evaluate the Objective Response Rate (ORR) of 6 cycles of Fol- CHOP Secondary Objectives: 1) To evaluate the Progression-free Survival (PFS) in patients treated with 6 cycles of Fol-CHOP 2) To evaluate the safety and tolerability of pralatrexate in combination with CHOP (Fol- CHOP). 3)To evaluate the pharmacokinetics (PK) of pralatrexate when given in combination with CHOP.
IRB Review and Approval Date: 02/09/2016
Recruitment Status: Open
Projected Accrual: 30
1) Patient must be willing and able to give written informed consent, be
able to adhere to dosing and visit schedules, and meet study requirements.
2) Patient must have newly diagnosed, untreated, histology-proven PTCL based on local pathology review, and eligible for CHOP chemotherapy.
3) Patient is at least 18 years of age.
4) Patient must have adequate hematologic, hepatic, and renal function as defined by: ANC >/=1.5×10^9/L; Platelet count >/=100×10^9/L; Bilirubin </=1.5 mg/dL; Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) </=2.5 upper limit of normal (ULN); Creatinine </=1.5 mg/dL or calculated creatinine clearance >/=50 mL/min.
5) Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
6) Patient must be willing to practice two forms of contraception, one of which must be a barrier method from study entry until at least 90 days after the last dose of study treatment.
7) Females of childbearing potential must have a negative urine pregnancy test within 30 days prior to enrollment. 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.
1) Patient with an 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) Patient with congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
3) Patient with uncontrolled hypertension.
4) Patient with central nervous system (CNS) metastases.
5) Patient with active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment.
6) Patient has had major surgery within 30 days prior to enrollment.
7) Patients has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
8) Patient has had previous exposure to pralatrexate.
9) Patient is pregnant or breast-feeding.
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